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2.2. Diet, Physical Activity and Weight Data Collection | Both the postnatal diet and PA data collection and coding replicated the methods used during the pregnancy phase of the study, which have been published [PA data were collected using the 32-item validated Pregnancy PA Questionnaire (PPAQ), including questions about the type and duration of activity in the previous week [Women were asked to have their weight measured by a health professional at each postnatal questionnaire time point (3-, 6-, 9- and 12-months) to be provided to the research team or to provide a printed copy of their weight measurement from scales in health centres or pharmacies at each time point. We could not access postnatal weight measurements from medical records as these are not routinely collected. We used pregnancy weight measurements to estimate weight change at each postnatal time point from the 1st-trimester booking appointment (mean gestational age 11.2 weeks, SD 4.1) and the 3rd trimester (36 weeks’ gestation). Pregnancy weight data collection methods have been published [ | PMC10490453 |
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2.3. Data Analysis | obesity | OBESITY | Not all participants completed each follow-up questionnaire. Therefore, cross-sectional analysis was undertaken at each postnatal time point. As these are pilot data, descriptive analysis was carried out on women’s diet, PA, and weight change data at 3-, 6-, 9- and 12-months postnatal to explore patterns. Comparison of behaviours between categories of obesity class, breastfeeding status, deprivation status, ethnicity, and dietary preference (i.e., vegetarians vs. non-vegetarians) was planned to be undertaken, but due to the small sample size and limited numbers within some sub-categories, this was not possible. The outcome data were tested for normality using the Shapiro-Wilkes test; data that were normally distributed are presented as means and standard deviations (SD), and data that are non-normally distributed as median and interquartile ranges (IQR). Diet data reported are for food types, with average daily consumption (e.g., mL/day milk consumed) and number and percent consuming the food item type (e.g., reduced fat, full fat). PA outcomes are average total energy expenditure (EE) per week and EE in each intensity category and from each PA domain. Weight change data reported are for average change at each postnatal time point from both 1st and 3rd trimesters of pregnancy, as well as a comparison for average weight change among women with excessive or non-excessive GWG. | PMC10490453 |
3. Results | PMC10490453 |
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3.1. Participants Characteristics | In total, 39 women who returned pregnancy questionnaires also returned postnatal questionnaires at one or more time points (38%) between March 2018 and June 2019. At 3-, 6-, 9- and 12-months postnatal, the socio-demographic, diet and PA data were available for 24 (23.1%), 22 (21.2%), 12 (11.5%) and 20 (19.2%) women, respectively. Weight data were available for 20 (19.2%), 22 (21.2%), 11 (10.6%) and 20 (19.2%) women respectively. At nine months postnatal, one NHS trust did not send out any questionnaires, which explains the relatively low response at this postnatal time point compared with others. There were no significant differences in the socio-demographic characteristics of the women who returned the questionnaire compared to those who did not (Across the four postnatal time points, there was minimal difference in the median BMI, ranging from 35.0 to 36.6 kg/m | PMC10490453 |
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3.2. Dietary Behaviours | Across the postnatal time points, the median milk intake was 142 mL/day, spread ranged from 5–10 g/day, and cheese 4–12 g/day ( | PMC10490453 |
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3.3. Physical Activity Behaviours | Reported levels of PA showed a pattern towards higher median EE with each postnatal time point, from 213.4 MET-hr/week at 3-months postnatal to 300.7 MET-h/week at 12-months ( | PMC10490453 |
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3.4. Postnatal Weight Change | 3rd-trimester, weight loss | All women in this study had their weight recorded at their booking appointment, and at least one postnatal weight was available for 35 women. The last recorded postnatal weight for 21 women (60%) was lower than their booking weight. When looking at weight change, the median values across all time points showed weight loss compared to both booking (−0.8 to −2.3 kg) and 3rd-trimester weight (−9.0 to −11.6 kg), although the IQRs showed that some women gained weight ( | PMC10490453 |
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4. Discussion | obesity, 3rd-trimester, weight loss | OBESITY, SECONDARY | This secondary analysis has provided novel data on postnatal diet, PA, and weight change among a highly deprived population of women living with obesity in the UK. This population had a suboptimal dietary intake, particularly regarding fruit and vegetables, unrefined breakfast cereals, fish, and oily fish, which did not meet national recommendations. Additionally, guideline recommendations are to limit the consumption of red meat and processed meat and fish, with no more than 70 g/day, whereas the median intake in this population was higher than these recommendations at most postnatal time points. Light-intensity PA contributed most to overall EE across all time points, whereas guideline recommendations are for at least 150 min/week of moderate-intensity PA. Overall, most EE was from the household/care PA domain, suggesting this might be an area for interventions to focus on, for example, supporting women to increase the intensity of activity in domains they are already participating in. There was a pattern towards weight loss across all postnatal time points when compared with 1st- and 3rd-trimester weights, with the greatest weight loss observed at 3-months postnatal and among women whose GWG was not excessive. Interventions could focus on limiting GWG as part of a preconception strategy for subsequent pregnancies and supporting women to maintain early postnatal weight loss from three months and throughout the 12-months.There is little existing evidence exploring postnatal diets of women in the UK. However, the findings in this study are similar to international studies in both the USA [Furthermore, Stephenson et al. [There is a lack of research in the UK focusing on women living with obesity in the postnatal period to compare our findings with. However, our findings are similar to those reported in the general postnatal populations. Our study showed increasing median EE over the postnatal period, and an Australian cross-sectional study also showed that sitting time was highest and PA levels lowest in the first six months postnatal, increasing significantly between 6–12 months [In our study, there was an overall pattern for weight loss in the postnatal period compared with booking or 3rd-trimester weights, and 60% of women had postnatal weights lower than their booking weight. These patterns are similar to a secondary analysis of the UK UPBEAT trial in women with obesity, which showed 52% had a lower weight at 6-months postnatal than in their 1st-trimester [In our study, we could not explore postnatal behaviour and weight change patterns according to breastfeeding status as planned due to too few women breastfeeding. At 3-months postnatal, only 20% were breastfeeding, and 27% at 6-months, lower than the population average outlined in the latest UK-wide infant feeding survey (34% at 6-months) [ | PMC10490453 |
Strengths and Limitations | obesity | OBESITY, SECONDARY | This is one of the first studies to explore the postnatal dietary and PA behaviours of women living with obesity in an area of high deprivation in the UK. Extensive data were collected as part of the GLOWING pilot trial, providing a rich dataset for analysis. However, this study was a secondary data analysis with a small sample size. Therefore, it was not designed to be an observational study or powered to detect statistical differences or make inferences at the population level. Loss to follow-up was high, and longitudinal analysis was not possible. However, there were limited statistically or clinically significant differences in the socio-demographics of women who returned questionnaires compared with those lost to follow-up. The sample sizes limited the ability to explore diet and PA behaviours or weight change between population subgroups, including by ethnic group, obesity category, or deprivation. Within the study population, women were predominantly white, employed, and could speak English, which may not reflect other UK regions. Data collection using FFQs and PPAQ has benefits in relation to low-resource options to reach many participants. However, both are subjective, relying on memory, literacy and numeracy skills and are subject to recall bias [This study identified many areas for future research, along with reflections from the research team on resolving some of the issues relating to loss to follow-up. Pregnancy and the postnatal periods are times of transition, including moving home due to a growing family. We lost some participants to follow up due to this (e.g., questionnaires were returned with “no longer at this address” written on them), and some women whom we had alternative contact details (e.g., those consenting to be interviewed as well as completing questionnaires provided email addresses or phone numbers) reported that they had moved and had not received the questionnaire. In the questionnaires, women were asked to state if they preferred paper or online versions, and paper was the main preference. However, this method does not have the flexibility that electronic follow-up would have, as email addresses are less likely to change. Additionally, posting questionnaires for follow-up was led by busy research midwife teams within the NHS Trusts, including one Trust that did not send out any questionnaires during the 9-month follow-up period. In future studies, keeping consent for contact details with university research teams for follow-up may be beneficial. Reducing loss-to-follow-up would allow a longitudinal study to be undertaken, offering important insights that could inform the development of personalised preconception interventions. | PMC10490453 |
5. Conclusions | obesity, weight loss | OBESITY | The postnatal period is important for the mother’s long-term health, as well as preconception health for those who have subsequent pregnancies. This descriptive study suggests that, among a highly deprived population of women living with obesity in the UK, postnatal diet and PA behaviours are inadequate and do not meet guideline recommendations. However, while there is variation at the individual level, the patterns in postnatal weight loss are promising, and suggest that strategies to limit excessive GWG and to support early postnatal weight loss may be beneficial for women to achieve postnatal weights lower than their 1st-trimester weight; therefore, having an impact on subsequent pregnancies. These data support the need to focus on the postnatal period as a preconception period. However, early provision of preconception support should also be extended to pregnancy with a more joined-up approach between pregnancy and postnatal stages. Further longitudinal research is required to explore these findings in a larger population of deprived women living with obesity to better understand postnatal behaviours and weight patterns and to inform the development of interventions to tackle inequalities in maternal obesity and subsequent pregnancy outcomes. | PMC10490453 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10490453 |
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Author Contributions | N.H. | Conceptualization, N.H., E.M., J.R., F.F.S. and C.M.; methodology, N.H., E.M., J.R., A.C.F., L.S., C.B., E.C. and F.F.S.; validation, N.H., E.C., L.S., C.B. and C.M.; formal analysis, N.H., E.C., C.M., C.B., L.S. and A.C.F.; investigation, N.H. and C.M.; data curation, N.H., C.M., E.M., J.R. and F.F.S.; writing—original draft preparation, N.H., E.C., C.B., L.S., C.M. and A.C.F.; writing—review and editing, all authors; supervision, N.H.; project administration, E.C.; funding acquisition, N.H., E.M., J.R. and F.F.S. All authors have read and agreed to the published version of the manuscript. | PMC10490453 |
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Institutional Review Board Statement | This study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Proportionate Review Sub-committee of the Yorkshire and The Humber—South Yorkshire Research Ethics Committee (ref: 15/YH/0565, 16 December 2015). | PMC10490453 |
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Informed Consent Statement | Informed written consent was obtained from all participants involved in this study. | PMC10490453 |
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Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to ethical approval restrictions, and any further data sharing will be subject to necessary approvals. | PMC10490453 |
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Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the study’s design, in the collection, analyses, or interpretation of data, in the writing of the manuscript, or in the decision to publish the results. | PMC10490453 |
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Background | PERIODONTITIS, INFLAMMATORY DISORDER | During the last decades, in patients with periodontitis, periodontal treatment has been shown to reduce the potential release of local and systemic biomarkers linked to an early risk of systemic inflammatory disorders. This study evaluated the efficacy of non-surgical-periodontal treatment (NSPT) on growth differentiation factor 15 (GDF-15) and related circulating biomarkers such as glutathione peroxidase 1 (GPx-1), c-reactive protein (hs-CRP), and surfactant protein D (SP-D) in periodontal patients and explored whether subjects who had high GDF-15 levels at baseline showed increased clinical benefits following NSPT at 6-months follow-up. | PMC10440880 |
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Methods | periodontitis | PERIODONTITIS | For this two-arm, parallel randomized clinical trial, patients with periodontitis were randomly allocated to receive quadrant scaling and root-planing (Q-SRP, n = 23, median age 51 years old) or full-mouth disinfection (FMD, n = 23, median age 50 years old) treatment. Clinical and periodontal parameters were recorded in all enrolled patients. The primary outcome was to analyse serum concentrations changes of GDF-15 and of GPx-1, hs-CRP, and SP-D at baseline and at 30, 90, and 180-days follow-up after NSPT through enzyme-linked immunosorbent assay (ELISA) and nephelometric assay techniques. | PMC10440880 |
Results | In comparison with FMD, patients of the Q-SRP group showed a significant improvement in clinical periodontal parameters (p < 0.05) and a reduction in the mean levels of GDF-15 (p = 0.005), hs-CRP (p < 0.001), and SP-D (p = 0.042) and an increase of GPx-1 (p = 0.025) concentrations after 6 months of treatment. At 6 months of treatment, there was a significant association between several periodontal parameters and the mean concentrations of GDF-15, GPx-1, hs-CRP, and SP-D (p < 0.05 for all parameters). Finally, the ANOVA analysis revealed that, at 6 months after treatment, the Q-SRP treatment significantly impacted the reduction of GDF-15 (p = 0.015), SP-D (p = 0.026) and the upregulation of GPx-1 (p = 0.045). | PMC10440880 |
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Conclusion | The results evidenced that, after 6 months of treatment, both NSPT protocols improved the periodontal parameters and analyzed biomarkers, but Q-SRP was more efficacious than the FMD approach. Moreover, patients who presented high baseline GDF-15 and SP-D levels benefited more from NSPT at 6-month follow-up. | PMC10440880 |
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Trial registration | NCT05720481. | PMC10440880 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12903-023-03237-y. | PMC10440880 |
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Keywords | PMC10440880 |
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Introduction | periodontitis, CVD, tooth loss, Periodontitis, heart failure | ENDOTHELIAL DYSFUNCTION, CVD, PERIODONTITIS, PERIODONTITIS, HEART FAILURE, INFLAMMATORY DISEASE, INFLAMMATORY RESPONSE | Periodontitis is a chronic, multifactorial, inflammatory disease caused by infectious biofilm that, if not prevented and treated appropriately, might destroy the tooth-supporting tissues and cause tooth loss [Recently some cohort clinical trials have shown that the growth differentiation factor 15 (GDF-15), a biomarker released in cardiac and blood wall tissues in response to heart volume expansion or abnormal pressure load, is associated with early diagnosis and bad outcomes in patients with CVD and heart failure [In periodontitis patients, previous reports have shown that upregulated GDF-15 levels sustain the inflammatory response of periodontal ligament fibroblasts against Finding mediators that might improve the predictive accuracy of systemic inflammatory risk and assessing the impact of periodontal therapy on early indicators of CVD and endothelial dysfunction are of increasing interest. In this regard, the purpose of the present randomized clinical trial (RCT) was to evaluate the effect of NSPT performed either through Q-SRP or FMD on GDF-15, GPx-1, hs-CRP, and SP-D concentrations in patients with periodontitis at 6-month follow-up after treatment. In addition, it was analyzed the impact of both NSPT protocols on serum GDF-15, GPx-1, hs-CRP, and SP-D, and if patients who harboured high baseline GDF-15 and related biomarkers levels benefited more from the efficacy of NSPT. The null hypothesis to invalidate was that, at the 6-month follow-up, there were no significant changes in serum GDF-15, GPx-1, hs-CRP, and SP-D among enrolled patients treated with different NSPT and that baseline biomarkers did not impact the efficacy of NSPT. | PMC10440880 |
Materials and methods | PMC10440880 |
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Study design and sample | periodontitis, bleeding, PD, tooth | PERIODONTITIS, BLEEDING, ALVEOLAR BONE LOSS, PLAQUE | The present RCT was performed according to the 2016 Helsinki Declaration on medical research. The ethical approval was obtained from the International Review Board of the University of Catania, Catania, Italy (22–149 PO). All participants signed the research informed consent; the study was retrospectively registered on clinicaltrials.gov (NCT05720481–09/02/23). The study was conducted in accordance with the CONSORT guidelines [For the present RCT, consecutive patients with a diagnosis of periodontitis [The inclusion criteria were (1) good general health, (2) a minimum of six teeth per quadrant, (3) at least two teeth in each quadrant with a probing depth (PD) ≥ 5 mm and a clinical attachment loss (CAL) ≥ 4 mm, (4) at least 40% of periodontal sites with bleeding on probing (BOP), and (5) at least 2 sites with radiographically verifiable alveolar bone loss (ABL) [After the identification of each eligible participant, medical history, demographic aspects such as age, gender, body mass index (BMI), comorbidities (if present), medicines, and levels of education recording of PD, BOP, gingival recession, and plaque index score was carried out. BMI (kg/mSubsequently, all recruited patients received a comprehensive dental and oral examination performed by 2 masked examiners. The periodontal examination was achieved using a conventional periodontal probe at six sites per tooth (UNC-15, Hu-Friedy, Italy), recording PD, BOP [ | PMC10440880 |
Sample size and reliability analysis | The power sample analysis, calculated using statistical software (G* POWER, Universität Düsseldorf, Germany), was obtained by setting up serum GDF-15 as a primary outcome variable [An inter-examiner reliability test among examiners (S.S., A.L.G.) was performed using Cohen’s kappa coefficient and showed an agreement of 85.8% (k = 0.63) for the primary outcome chosen, CAL, indicating a high degree of reliability. The kappa coefficient was also calculated for the measurements taken at each follow-up session, and an acceptable degree of reliability was established for every examination (intra-class correlation coefficient, ICC = 0.770). | PMC10440880 |
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Randomization | Through a permuted block design, the randomization was performed by a single clinician, not involved in the subsequent trial stages, which generated a random assignment of a treatment using a sequence 1:1 ratio by a computer random-number generator.Each patient was allocated to receive Q-SRP or FMD. The allocation was concealed to the clinician who performed the NSPT protocol using serially numbered, sealed envelopes, and the sequence details were concealed from all other clinicians. Before each treatment, a clinician who was not engaged in data processing assigned the patient’s treatment to a sealed envelope containing the treatment’s name and initials.Just prior to each treatment session, a clinician not involved in the subsequent study stages opened the envelope containing the patient’s assigned therapy which he handed to the clinician for treatment. To eliminate bias in the experimental data, all the procedures were performed by the same blinded clinician with ten years of expertise in periodontics. | PMC10440880 |
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Study outcomes | SECONDARY | The primary outcome was the analysis of serum GDF-15 expression changes between groups after 6 months following NSPT protocols. Furthermore, the impact of NSPT on GPx-1, hs-CRP, and SP-D concentration changes was analysed after 6 months of treatment. The secondary objective was to examine the influence and interaction between NSPT protocol (Q-SRP used as a reference) and the duration of NSPT (6 months) on GDF-15, GPx-1, hs-CRP, and SP-D changes, as well as whether high baseline levels of GDF-15, GPx-1, hs-CRP, and SP-D influenced the efficacy of periodontal treatment after 6 months of follow-up. | PMC10440880 |
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Treatment | Shortly after the baseline assessments, each enrolled patient received oral hygiene instructions. Patients allocated to the FMD group received a full mouth SRP in one side of the mouth for each session, within 24 h in two separate sessions, on two consecutive days with the adjunctive use of local antiseptic in accordance with the protocol of Patients allocated to the Q-SRP group received quadrant SRP in four different sessions with an interval of 1 week. In each patient, the first session started in the upper right maxillary quadrant. Treatments were recorded in minutes and performed under local anaesthesia only if necessary. At the conclusion of each type of treatment, all patients undergo to periodontal supportive therapy in which each patient was motivated to reinforce domiciliary oral hygiene measures. | PMC10440880 |
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Sampling | At baseline and at 3- and 6 months after NSPT, blood samples from each patient were taken between 8:00 and 10:00 a.m., before any periodontal examination. Following sampling, serum samples were centrifuged at 4 °C (1000x g for 2 min) and stored. The serum GDF-15, GPx-1, and SP-D concentration levels were obtained using a specific kit according to the manufacturer’s instructions and were evaluated using human-specific enzyme-linked immunosorbent assay (ELISA) kits. The hs-CRP levels were obtained by a nephelometric assay kit. | PMC10440880 |
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Statistical analysis | SECONDARY | Numerical data were expressed by mean ± standard deviation (SD), while categorical variables were reported as numbers and percentages. Because most of the analyzed variables were not normally distributed, as verified by the Kolmogorov-Smirnov test, a non-parametric approach was applied. The Mann-Whitney test was used for the numerical data comparison between groups, while the Chi-Square test was applied for the comparisons between categorical variables. The single patient was set as a test unit. For intragroup comparisons, the Friedman test was applied to compare numerical variables over four-time intervals (baseline, 30, 90, and 180 days), whereas the Wilcoxon test was used for two-by-two comparisons across dependent groups. Bonferroni’s correction was applied for multiple comparisons, and the alpha level of 0.050 was set and was divided by the number of potential comparisons (baseline, 3 months, 6 months) to get an adjusted significance level of 0.017 (0.050/3). The Spearman’s correlation test was used to examine a potential substantial dependency between GDF-15, GPx-1, hs-CRP, and SP-D and all analyzed variables at a 6-month follow-up.To analyze the effect of the treatment protocols on GDF-15, GPx-1, hs-CRP, and SP-D (continuous variables), a two-way ANOVA was used to estimate whether the mean of the quantitative variable (GDF-15, GPx-1, hs-CRP, and SP-D) changes based on the levels of two categorical variables, treatment and timing of treatment. Specifically, it was evaluated how the two independent variables (treatment protocols and timing), alone and in combination, influenced serum GDF-15 concentration changes. The same models were applied for the secondary outcomes GPx-1, hs-CRP, and SP-D changes. Statistical analyses were performed using IBM SPSS version 22 Statistical software for Windows (Armonk, NY, IBM corp). A significant P-value was set as < 0.05. | PMC10440880 |
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Results | PMC10440880 |
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Primary outcome | Bleeding, PD | BLEEDING, PLAQUE | In comparison with the FMD group, at 6 months after therapy, the Q-SRP group showed a significant reduction of the GDF-15 levels (p = 0.012) (Table
Differences among GDF-15, GPx-1, hs-CRP and SP-D at baseline and at each follow-up session. Results are expressed as mean and SD (standard deviation). a, significance between baseline and 30 days; b, significance between baseline and 90 days; c, significance between baseline and 180 days; d, significance between 30 and 90 days; e, significance between 30 and 180 days; f, significance between 90 and 180 days. * P-value significant < 0.008 (Bonferroni corrections). GDF-15, growth differentiation factor 15; GPx-1, glutathione peroxidase 1; hs-CRP, c-reactive proteins; SP-D, surfactant protein DAt 6-months of therapy, the correlation analysis evidenced that there was a correlation between serum GDF-15 and smoking (p = 0.046), % sites with PD ≥ 4 mm (p = 0.022), number of teeth (p = 0.031), BOP (p = 0.044) and PI (p = 0.045). Serum GPx-1 levels were correlated with smoking (p = 0.044), HbA1c (p = 0.045), LDL-cholesterol (coeff. 0.196, p = 0.044), number of teeth (p = 0.041), CAL (p = 0.025) and BOP (p = 0.027); hs-CRP was correlated with HbA1c (p = 0.048), LDL cholesterol (p = 0.019), % sites with PD ≥ 4 mm (p = 0.032), BOP (p = 0.045), and PI (p = 0.039); SP-D levels were correlated with smoking (p = 0.025), number of teeth (p = 0.035); CAL (p < 0.001), BOP (p = 0.016), and PI (p = 0.011) (Table
Correlation analysis among GDF-15, GPx-1 and the analyzed variables at 6-months of treatment. For sex, males served as a reference. GDF-15, growth differentiation factor 15; GPx-1, glutathione peroxidase 1; hs-CRP, c-reactive proteins; SP-D, surfactant protein D. HbA1c, Glycated haemoglobin; BMI, Body Mass Index, PD, Probing Depth; CAL, Clinical Attachment Loss; BOP, Bleeding on Probing; PI, Plaque Index | PMC10440880 |
Secondary outcome | INTERACTION | The estimation of models aimed to determine the impact of Q-SRP and timing of treatment on GDF-15, GPx-1, hs-CRP, and SP-D concentration changes at 6 months using a two-way ANOVA test revealed that Q-SRP had a significant effect on the reduction of serum GDF-15 (p = 0.015), GPx-1 (p = 0.045), and SP-D (p = 0.045) together with the timing of treatment for GDF-15 (p = 0.028) and GPx-1 (p < 0.001) concentrations. More specifically, patients with high GDF-15, GPx-1, and SP-D baseline concentrations gained more benefits from Q-SRP at 6-month follow-up (Table
Results of two-way ANOVA for the dependent variable GDF-15, GPx-1, hs-CRP and SP-D. GDF-15, growth differentiation factor 15; GPx-1, glutathione peroxidase 1; hs-CRP, c-reactive proteins; SP-D, surfactant protein DMS: Mean of Square. F: Fisher test; Group*Timing: Interaction term | PMC10440880 |
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Discussion | periodontitis, infection, CVD | SYSTEMIC DISEASE, CVD, PERIODONTITIS, CHRONIC INFLAMMATORY DISEASE, INFECTION, PERIODONTAL INFLAMMATION, INFLAMMATORY RESPONSE | In the last decade, an increasing amount of evidence has found that the chronic inflammatory stimulus linked to its pathogenic biofilm load is the real factor that directly connects periodontitis to many systemic diseases. Due to these factors, periodontal treatment, through its various approaches, has been shown to be of vital importance as a primary factor in managing the reduction of risk of development or aggravation of systemic diseases and endothelial damage. In this regard, a number of non-surgical instrumentation approaches that allow a stable reduction over time of possible early biomarkers of the risk of developing systemic chronic inflammatory diseases have been developed [At 6-months of treatment, both groups of patients demonstrated, compared to baseline, a significant improvement of all analyzed biomarkers. However, compared to FMD, Q-SRP treatment produced a greater decrease in serum GDF-15, hs-CRP, and SP-D levels associated with increased GPx-1 levels. In this regard, several studies evidenced that, during periodontitis, imbalanced serum GDF-15 levels may influence the innate host defences against periodontal pathogens [However, the therapeutic significance in reducing several systemic CVD and inflammatory risk biomarkers among various non-surgical periodontal treatment approaches is still poorly understood.In this regard, it has been shown a possible correlation between markers of low-grade periodontal inflammation and the etiology of CVD in patients with periodontitis, characterized by the periodontal microbial infection that stimulates the local and systemic production of pro-inflammatory cytokines such as TNF-, IL-1, and IL-6 [Furthermore, the important clinical indicators of CVD include, among others, CRP, interleukin-6 (IL-6), lipid index, fibrinogen, tumor-necrosis factor-α (TNF-α) and GCF-15 [In this regard, the present study has achieved significant results with Q-SRP approach with a positive correlation between serum GDF-15, GPx-1, hs-CRP and SP-D with the extent of periodontitis, evaluated through the association with the several periodontal parameters examined. Therefore, the reduction in serum GDF-15, hs-CRP and SP-D levels 6 months after periodontal therapy with Q-SRP implies that this therapy was able to determine a more effective breakdown of the bacterial biofilm and a superior host response compared to the FMD approach.Furthermore, the two-way ANOVA analysis of the present investigation demonstrated that Q-SRP significantly improved and impacted serum GDF-15, GPx-1 and SP-D after six months of therapy. In addition, the same analysis demonstrated that at six months follow-up, patients who harboured high levels of GDF-15 and SP-D and low levels of GPx-1 before periodontal treatment positively benefited from the periodontal treatment efficacy at 180 days follow-up. In this regard, it has been demonstrated that periodontal treatment can induce a short-term inflammatory response resulting in a progressive and consistent reduction in systemic inflammatory biomarkers [The present study had some limitations that should be addressed, such as the monocentric design and the short-term evaluation timing. More specifically, a longer follow-up and a higher number of enrolled patients would have been beneficial to assess the positive impact on differential clinical results for stable periodontal outcomes. Furthermore, a test group of CVD patients may have been needed to better determine the impact of periodontal treatment in reducing biomarkers linked with CVD. For these reasons, further analyses are required to better understand the benefits of non-surgical periodontal treatments on serum GDF-15 GPx-1, hs-CRP and SP-D.In conclusion, the findings of the present randomized controlled trial demonstrated that, in all analyzed patients, both Q-SRP and FMD treatments were efficacious, at 6 months, in reducing periodontal parameters as well as serum CVD biomarkers. However, periodontal treatment performed with Q-SRP determined a better decrease in clinical periodontal parameters and improved GDF-15, GPx-1, hs-CRP and SP-D in patients with periodontitis. In addition, there is a tendency towards a more beneficial effect of periodontal treatment at 6 months if patients presented higher GDF-15 and SP-D and lower GPx-1 concentrations at baseline. | PMC10440880 |
Acknowledgements | The authors acknowledge the staff of the Unit of Periodontology, School of Dentistry, of the University of Catania for their support. | PMC10440880 |
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Authors’ contributions | G.I. conceived the research, planned and performed the experimental procedures and wrote the manuscript. G.M.T., A.L.G. and S.S. performed the procedures. A.C. and A.M. validated the experimental results and revised the manuscript. All authors reviewed the manuscript. | PMC10440880 |
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Funding | The present research was funded by funds of the University of Catania, Italy, Grant | PMC10440880 |
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Data Availability | Data are available from corresponding authors upon reasonable request. | PMC10440880 |
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Declarations | PMC10440880 |
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Ethics approval and consent to participate | International Review Board of the University of Catania approved the study protocol (22–149 PO). All patients signed an appropriate written informed consent for the study participation. The present RCT was performed according to CONSORT criteria and the 2016 Helsinki Declaration on medical research. | PMC10440880 |
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Consent for publication | Not Applicable. | PMC10440880 |
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Competing interests | The authors declare that they have no conflict or competing interests in the present study. | PMC10440880 |
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References | PMC10440880 |
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1. Introduction | T1DM, fatigue, LCD, Diabetes, diabetes | DIABETIC KETOACIDOSIS, TYPE 1 DIABETES MELLITUS, TYPE 1 DIABETES MELLITUS, HYPOGLYCEMIA, GLYCOGEN DEPLETION, GROWTH DELAY, DYSLIPIDEMIA, DIABETES, DIABETES | Objective: The aim of this study was to evaluate the macronutrient and micronutrient intake and status in youth with type 1 diabetes mellitus (T1DM) following the consumption of a low-carbohydrate diet (LCD). Research Methods and Procedures: In a prospective intervention clinical trial, adolescents with T1DM using a continuous glucose monitoring device were enrolled. Following a cooking workshop, each participant received a personalized diet regime based on LCD (50–80 g carbohydrate/day). A Food Frequency Questionnaire was administered, and laboratory tests were taken before and 6 months following the intervention. Twenty participants were enrolled. Results: The median age was 17 years (15; 19), and the median diabetes duration was 10 years (8; 12). During the six-months intervention, carbohydrate intake decreased from 266 g (204; 316) to 87 g (68; 95) (Type 1 diabetes mellitus (T1DM) is one of the most common endocrine and metabolic conditions in childhood and is often characterized by poor glycemic control [Carbohydrates are the primary macronutrient that affects the postprandial glycemic response. The international guidelines published by the International Society of Pediatric and Adolescent Diabetes include 40–50% of total energy consumption from carbohydrates, and achievement of optimal postprandial glycemic control with appropriately matched insulin to carbohydrate ratios and insulin delivery [The lower consumption of carbohydrates essentially lowers the glycemic response and the insulin requirement. Although LCD has a promising effect on glycemic control, endorsing the regime may lead to harmful dietary consequences. This is due to the complete or partial avoidance of healthy sources of carbohydrate foods such as whole grain bread, cereals, legumes, fruit, and vegetables.In individuals with T1DM, adverse health risks such as diabetic ketoacidosis, hypoglycemia, dyslipidemia, glycogen depletion, and growth impairment remain clinical concerns. In an illustrative case series of children with T1DM who were on LCD, some experienced growth delay and fatigue [Parents or people with T1DM who choose LCD usually do so without proper medical guidance and may put their child or themselves at risk of nutritional depletion of essential nutrients and minerals. Studies examining glycemic outcomes from LCD have largely been cross-sectional and without validated dietary data [In the current study, we aimed to investigate the effect of an LCD intervention on macronutrient and micronutrient intake and status in youth with T1DM. | PMC10051868 |
2. Materials and Methods | PMC10051868 |
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2.1. Participants and Study Design | T1DM, Diabetes | DIABETES | This report documents a prospective intervention clinical trial conducted in the Pediatric Endocrinology and Diabetes Unit at the Sheba Medical Center. Eligibility criteria were a diagnosis of T1DM according to the American Diabetes Association criteria [ | PMC10051868 |
2.2. Diet Intervention | At baseline, each participant underwent a cooking workshop and received a personalized diet regime based on the LCD. For participants younger than 18 years, nutrition education was provided to both the participants and their parents. Participants met individually with a dietitian for diet instructions and support at weeks 1, 2, 4, 7, 10, 12, and 24, for a total of seven frontal meetings. Twice during the first 12 weeks, the dietician conducted 10–15-min motivational telephone calls with each participant. During the entire course of the study, every participant had the option of consulting with the study’s dietitian ( | PMC10051868 |
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2.3. Low-Carbohydrate Diet | The LCD aimed to provide 50–80 g/day of carbohydrates. There was no caloric restriction, but each patient received a weekly plan with main meals and snacks. The planned macronutrient composition of the diet (percentage of total calories) was: 20% carbohydrate, 25% protein, and 55% fat. All the dietary details were stated in the protocol and approved by the IRB. | PMC10051868 |
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2.4. Assessment of Nutritional Composition | The habitual food consumption of the participants was evaluated using the Food Frequency Questionnaire (FFQ), which was taken at baseline and after six months of intervention. The FFQ included 116 food items commonly eaten in Israel, standard portion sizes, and a frequency response section. It is based on a validated FFQ used for determining the dietary intake of Israeli multiethnic populations [Using the Tzameret software, Israeli food and nutrient database, total energy intake (Kcal) and both macronutrients and micronutrients were calculated [ | PMC10051868 |
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2.5. Medical History and Anthropometric Measurements | diabetes | DIABETES | Age of diabetes onset, diabetes duration, and other medical diagnoses data were retrieved from medical records. Height, weight, and waist circumference were measured at each visit according to standardized protocol by trained and certified staff. Body mass index (BMI) was calculated as weight (kg)/height squared (m | PMC10051868 |
2.6. Biochemical Parameters | diabetic ketoacidosis | DIABETIC KETOACIDOSIS, BLOOD | Blood samples including HbA1c, total cholesterol, LDL cholesterol, and HDL cholesterol were collected under metabolic stability conditions. The latter were defined as no episode of diabetic ketoacidosis within 1 month before the visit and after ≥12 h of fasting. Laboratory results of serum C-reactive protein (CRP), blood urea nitrogen (BUN), creatinine, sodium, magnesium, calcium, zinc, phosphorous, vitamin B1, vitamin C, and folic acid were recorded. All fasting blood samples were taken at baseline and at 24 weeks, from a forearm vein and then processed by ELISA (Enzyme-Linked Immunosorbent Assay) at the Sheba Medical Center laboratories. | PMC10051868 |
2.7. Trial Outcomes | Our primary endpoint was nutritional vitamins and mineral status after 24 weeks of an LCD. Secondary outcomes were body weight and waist circumference at this time point. | PMC10051868 |
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2.8. Statistical Analysis | Categorical variables were described using frequencies and percentages. Continuous variables were expressed as medians and interquartile ranges (IQR, 25th; 75th percentiles). The Wilcoxon test was used to compare continuous variables before and after the 6-month period. Spearman’s correlation coefficient test was used to study associations between continuous variables; >0.36 was considered as a moderate correlation, while r > 0.67 was considered as a high correlation. All statistical tests were two-sided, and all | PMC10051868 |
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3. Results | PMC10051868 |
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3.1. Study Group Characteristics | obesity, T1DM, diabetes | OBESITY, DIABETES | Twenty adolescents with T1DM (14 females) were enrolled in the study at median (IQR) age of 17 years (15; 19). The median diabetes duration was 10 years (8; 12). Eighteen participants were treated with an insulin pump and two were treated with multiple daily injections. The median BMI z-score was 1.3 (0.65; 1.50); nine participants were categorized as having normal weight, seven were categorized as having overweight, and four were categorized as having obesity. The median waist circumference was 85.7 cm (80.0; 91.8), and the median percentile was 76.5% (55.2; 83.5). One female participant withdrew after 3 months as she found it challenging to manage the LCD ( | PMC10051868 |
3.2. FQQ | The median baseline percent from calories of carbohydrates was 44% (37; 47); from protein, 18% (16.5; 20); and from fat, 35% (30; 37). Baseline median percentages of micronutrients were calculated according to DRI values as follows: fiber 115% (97.5; 145.5), iron 101% (85; 138), magnesium 145% (118; 180), calcium 116% (82; 140.7), zinc 135% (111.2; 166.2), copper 158% (144; 182), vitamin B1 152% (136; 189), vitamin B2 229% (188; 264), vitamin B6 252% (199; 288), folate (vitamin B9) 123% (108; 143), vitamin B12 225% (200; 309), and vitamin C 359% (200; 471). After 6 months of the LCD intervention, the median intakes of several macronutrients and micronutrients were significantly different than at baseline ( | PMC10051868 |
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3.3. Weight Loss and Waist Circumference | The LCD was associated with significant reductions in median BMI z-scores ( | PMC10051868 |
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3.4. Blood Laboratory Measurements | The median (interquartile range) HbA1c level declined after LCD, from 8.1% (7.5; 9.4) to 7.7% (6.9; 8.2), | PMC10051868 |
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3.5. Correlations | Delta body weight was not correlated with any of the parameters examined. The delta of calories from ultra-processed food did not correlate with any of the macronutrients or micronutrients examined. | PMC10051868 |
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4. Discussion | T1DM, TIDM, LCD, metabolic syndrome, Nutritional deficiencies, diabetes | TRACE ELEMENT DEFICIENCY, AIDS, EVENTS, MAGNESIUM DEFICIENCY, NUTRITIONAL DEFICIENCIES, METABOLIC SYNDROME, DIABETES | In this novel study of youth with TIDM who followed LCD for six months, decreases were found in median intakes of several macronutrients and micronutrients. Median blood levels of several nutrients decreased. These changes were in parallel to an improved median HbA1c level and lower median values of CRP, BMI z-score, and waist circumference.The proportion of calories from ultra-processed food decreased during the intervention, because adherence to the LCD required more frequent cooking and less consumption of prepared food. Our findings are in concordance with a randomized trial among adults without diabetes [The decrease by 70% in carbohydrate intake shows good compliance of our participants throughout the study period. We believe that the workshops with food preparation and imparting knowledge, together with the careful supervision and frequent in-person meetings and phone calls contributed to the good adherence and compliance in our study.The decrease in carbohydrate intake was associated with reduced intakes of fibers and fructose. Low fiber intake was consistently demonstrated in several studies that investigated LCD [Decreased carbohydrate intake requires the substitution of another macronutrient, hence the fear that increased fat consumption could impair the lipid profile. However, among our participants, the fat intake did not change significantly after conversion to LCD due to calories decrease. Lipid profiles were not significantly elevated; these findings are in line with a 12-week crossover randomized study comparing high-carbohydrate diet versus LCD in 14 participants with T1DM [The reported FFQ showed significantly lower median intakes at the end of the intervention compared to baseline, according to percentages of recommended daily allowance of several minerals and vitamins (iron, calcium, phosphorus, vitamin B1). These findings are in agreement with a systematic review that showed deficient intakes of magnesium, calcium, iron, iodine, thiamine, and folate in healthy adults who followed a carbohydrate-restricted diet [Median intake levels of the trace elements iron and calcium were lower after the LCD than at baseline. Notably, a systematic review and case series described a lower intake of iron after conversion to LCD [In the present study, median serum zinc values were within the normal range both at baseline and at the end of the intervention in spite of a downward trend. Data on the effect of dietary zinc intake on its serum level remain inconclusive. This decrease in daily consumption may be due to the lack of legumes and grains in LCD. Zinc is an essential trace element found in food, playing a role in many antioxidative defense and metabolic processes, such as insulin processing, storage, secretion and action [Data indicated a decrease in copper intake. Copper is a vital mineral that aids in the production of neurotransmitters, connective tissue, neuropeptides, and energy [According to the FFQ, magnesium intake was significantly lower in our participants after the LCD; four participants had deficient magnesium plasma levels. Magnesium is an essential cation that is found in legumes, nuts, and vegetables. Of note, magnesium deficiency is the most prevalent trace element deficiency in individuals with T1DM [A 30% decrease in selenium intake was observed in our cohort despite instructed supplementation with Brazil nuts. Selenium is an essential trace element known to influence various physiological processes, including energy homeostasis, through its redox functions. It is used to synthesize selenoproteins, which is a family of proteins with mainly antioxidant roles [Our data demonstrated improved parameters of the metabolic syndrome such as weight, BMI z-score, waist circumference, and CRP, as well as improved glycemic control, among adolescents with T1DM following a 6-month LCD intervention. The high CRP levels observed at baseline corroborate a study of children with T1DM who had higher levels of CRP than a control group; elevated CRP has been linked to coronary events [For people with T1DM who follow LCD, we advise long-term and periodic monitoring of the nutrients whose intakes and blood levels decreased during the six months of our intervention. Nutritional deficiencies after LCD emphasize the need to provide nutritional substitutes that could fill the nutritional gaps [Our study has some limitations. As with all dietary recall studies, FFQ interviews are subject to recall bias. However, this recall method is considered more reliable than a single-day recall [ | PMC10051868 |
5. Conclusions | diabetes | DIABETES | Medical nutrition therapy remains a cornerstone of diabetes care [ | PMC10051868 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10051868 |
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Author Contributions | Neriya | Conceptualization, N.L. (Neriya Levran), A.A., E.M.-O. and O.P.-H.; Data curation, N.L. (Neriya Levran); Formal analysis, N.L. (Neriya Levran) and O.P.-H.; Investigation, N.L. (Neriya Levran), N.L. (Noah Levek) and B.S.; Methodology, O.P.-H.; Project administration, O.P.-H.; Supervision, E.M.-O. and O.P.-H.; Writing—original draft, N.L. (Neriya Levran) and O.P.-H.; Writing—review and editing, N.L. (Noah Levek), B.S., N.G. and E.M.-O. All authors have read and agreed to the published version of the manuscript. | PMC10051868 |
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Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethical Committee of Sheba Medical Centre (protocol number SMC-5537-18). Informed consent was obtained from obtained from all subjects involved in the study. | PMC10051868 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10051868 |
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Data Availability Statement | The data and the questioners are all in Hebrew and could be sent by a personal request. | PMC10051868 |
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Conflicts of Interest | The authors declare no conflict of interest related to this work. | PMC10051868 |
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Background | Since its beginnings in 2019, the COVID-19 pandemic is still a problem of global medical concern. Southern Vietnam is one of the country's vast regions, including 20 provinces and the densely populated metropolis Ho Chi Minh City. A randomized retrospective study was performed to investigate the epidemiology and genetic diversity of COVID-19. Whole-genome sequencing of 126 SARS-CoV-2 samples collected from Southern Vietnam between January 2020 and December 2021 revealed the main circulating variants and their distribution. | PMC10655423 |
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Methods | Epidemiological data were obtained from the Department of Preventive Medicine of the Vietnamese Ministry of Health. To identify circulating variants, RNA, extracted from 126 nasopharyngeal swabs of patients with suspected COVID-19 were sequenced on Illunina MiSeq to obtain near complete genomes SARS-CoV-2. | PMC10655423 |
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Results | Due to the effectiveness of restrictive measures in Vietnam, it was possible to keep incidence at a low level. The partial relaxation of restrictive measures, and the spread of Delta lineages, contributed to the beginning of a logarithmic increase in incidence. Lineages 20A-H circulated in Southern Vietnam during 2020. Spread of the Delta lineage in Southern Vietnam began in March 2021, causing a logarithmic rise in the number of COVID-19 cases. | PMC10655423 |
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Conclusions | Pandemic dynamics in Southern Vietnam feature specific variations in incidence, and these reflect the success of the restrictive measures put in place during the early stages of the pandemic. | PMC10655423 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12879-023-08814-8. | PMC10655423 |
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Keywords | PMC10655423 |
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Introduction | pneumonia | VIRUS, PNEUMONIA | In late December 2019, a group of patients with pneumonia of unknown etiology was reported in Wuhan, Hubei province, China [After applying many COVID-19 control measures (shutting down Wuhan on the 23rd of January, blocking all travel to and from the city), the daily number of cases in China subsequently decreased. In contrast, large clusters were reported in an increasing number other countries.In Vietnam, the first case was identified on January 23, 2020 [SARS-CoV-2 is an enveloped, positive-sense single-stranded RNA virus. Its 30 kilobase genome features a rapid mutation rate, and nucleotide changes accumulate over time. Identifying and following mutations helps to minimize adverse public health impacts. Southern Vietnam is one of three geographic regions which includes 20 provinces and a principal megalopolis, Ho Chi Minh, with a population of around 9 million people. Here, we studied the epidemiology of COVID-19, including whole-genome sequencing of SARS-CoV-2 samples from Southern Vietnam, during the period from January 2020 to December 2021. Identification of the main circulating variants during the pandemic in Vietnam and their succession is valuable information needed by scientists, policy makers, and health professionals. | PMC10655423 |
Materials and methods | PMC10655423 |
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Epidemiological data and study materials | All epidemiological data were obtained periodically from the Department of Preventive Medicine, Vietnamese Ministry of Health [ | PMC10655423 |
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RNA purification, Real-time PCR | Total RNA from nasopharyngeal swabs samples were obtained by extraction and purification using the QIAamp Viral RNA Extraction Kit (QIAGEN, Germany) with the QIAcube Connect automatic station (QIAGEN, Germany) according to the manufacturers recommendations. Samples were eluted and stored at -70° C until further analysis. For SARS-CoV-2 detection and to assess viral load, swabs were thoroughly analyzed using LightMix® Modular Wuhan CoV E-gene reagents (Roche SAP) according to manufacturer’s recommendations. SARS-CoV-2-positive samples featuring Ct values of 25 or less were selected and studied further. | PMC10655423 |
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SARS-CoV-2 genome enrichment | -20 | To create NGS libraries, viral RNA was subjected to reverse transcription and subsequent PCR enrichment. Reverse transcription was performed using random hexamers with the Reverta L Kit (AmpliSens, Russia) following the manufacturer's protocol. Samples (cDNA) were stored at -20°C until amplification. To obtain a near complete genome sequences of SARS-CoV-2 (excluding the 5′ and 3′ ends), a total of 138 primer pairs covering the entire genome were applied according to a previously described multiplex PCR protocol [ | PMC10655423 |
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Library preparation and sequencing | Library preparation was performed using the TruSeq DNA CD Indexes Kit (Illumina Inc., USA) according to the Illumina TruSeq Nano DNA Kit protocol. Sequencing was performed on a MiSeq instrument using MiSeq V3 chemistry, generating 2 × 200 bp reads. | PMC10655423 |
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Genome assembly | The quality of the Illumina reads was assessed using the FastQC program [ | PMC10655423 |
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Availability of data | Sequences were uploaded to GISAID under the following IDs for year 2020: EPI_ISL_812922, EPI_ISL_760247, EPI_ISL_17454567, EPI_ISL_17436319, EPI_ISL_17454569, EPI_ISL_654872-EPI_ISL_654874, EPI_ISL_17433648-EPI_ISL_17433661, EPI_ISL_654866-EPI_ISL_654870, EPI_ISL_654886-EPI_ISL_654889, and EPI_ISL_654875-EPI_ISL_654884. For 2021, the IDs were: EPI_ISL_16034578, EPI_ISL_16034555-EPI_ISL_16034573, EPI_ISL_16034575-EPI_ISL_16060862, and EPI_ISL_17433647. | PMC10655423 |
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Variant annotation and phylogenetic tree reconstruction | Variant calling files (.vcf) were processed for the effect of SNP variation with the SnpEff tool ( | PMC10655423 |
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Results | PMC10655423 |
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Epidemiology of SARS-CoV-2 in Southern Vietnam, 2020–2021 | MAY, VIRUS | The first COVID-19 cases were confirmed in Southern Vietnam on January 23, 2020, when two Chinese individuals arrived in Ho Chi Minh City and tested positive for the virus [COVID-19 incidence rate in Southern Vietnamese regions in 2020. Due to restrictions on movement and border crossing under strict quarantine, the incidence in 2020 in Southern Vietnam was sporadic. The incidence did not exceed 0.2 per 100,000 populationConsidering the situation in twenty provinces of Southern Vietnam, a total of 365 cases of COVID-19 were registered in 2020. Five provinces did not detect a single case: An Giang, Binh Phuoc, Hau Giang, Lam Dong, and Soc Trang. Almost half of all cases occurred in Ho Chi Minh City, Southern Vietnam's largest city (Table COVID-19 case numbers by province in 2020In January 2021, there was a relaxation of the ban on air travel, but only under certain conditions: if there was evidence of having completed a full course of COVID-19 vaccination (no later than 14 days before the intended visit to the country) as well as a negative test performed not more than 72 h earlier. During the first five months of 2021, the incidence rate remained at a consistently low level. In May 2021, the incidence rate was already 0.8 per 100,000 population. Despite previously successful public health measures, there has been a dramatic increase in cases since June 2021. The incidence rate rose from 16.8 in June to 851.9 by December 2021 (Fig. COVID-19 incidence rate in Southern Vietnamese regions in 2021. During the first five months of 2021, the incidence rate remained at a consistently low level. In May 2021, the incidence rate increased to 0.8 per 100,000 population. Since June 2021, there has been an increase in the number of cases from 16.8 in June to 851.9 by December 2021COVID-19 case numbers by province in 2021The maximum increase in the number of COVID-19 cases in the second half of 2021 was observed in the three provinces closest to Ho Chi Minh City. Binh Duong province recorded 287,282 total cases in 2021. The southern districts of Binh Duong province are very urbanized and are within one of the districts of Ho Chi Minh City. The population is about 2.5 million people. Currently, Binh Duong is a zone of ecotourism, alongside a focus on historical and cultural relics. In the provinces of Dong Nai and Tay Ninh, 96,762 and 83,488 cases were detected, respectively. Due to their large populations, proximity to Ho Chi Minh City, and natural mobility of the population, these provinces experienced a high rate of increase in COVID-19 incidence (Table | PMC10655423 |
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Mutations in the SARS-CoV-2 spike protein gene in samples from Vietnam | MINOR | Of 126 genomes that underwent sequencing, 55 S gene sequence variants (SGSV) were identified based on SNP pattern. SGSV-1 was identical to the Wuhan-Hu-1/2019 (MN908947) reference strain without any SNPs or indels. The remaining 54 SGSVs had at least one SNP compared to the reference (Figs. Four different SGSVs were identified within the analyzed strains. Strains from clade 20C were identical by S gene sequence with only the single defining mutation (D614G), and they carried SGSV-9. Clade 20D samples had a single defining mutation (D614G) and a synonymous 23,731 C > T SNP. Clade 20E (EU1), apart from the defining A222V variant, had a synonymous 23,683 C > T (Fig. Phylogenetic comparison and heatmap analysis of variations observed in clades 19A-B and 20A-H. The figure shows the phylogenetic diversity and analysis of variations observed in lineages 19AB and 20A-H based on S gene sequence. Mutations were found relative to the Wuhan-Hu-1/2019 (GenBank: MN908947) reference strain. SGSV – S gene sequence variants. Clades in which this pattern occurs are indicated in parentheses. The number of strains of the specified variant in the studied group is indicated by a colonPhylogenetic comparison and heatmap analysis of variations observed in Delta clades. In 2021, most strains from domestic and imported cases were in the Delta VOC, major lineage 21I, and minor lineages 21A and 21J. The figure shows the phylogenetic diversity and analysis of variations based on S gene sequence. Mutations were found relative to the Wuhan-Hu-1/2019 (GenBank: MN908947) reference strain. SGSV – Sgene sequence variants. Clades in which this pattern occurs are indicated in parentheses. The number of strains of the specified variant in the studied group is indicated by a colonIn 2021, the majority of samples from domestic and imported cases belonged to the Delta VOC, major clade 21I, and minor clades (21A, 21 J). Altogether, forty SGSVs within the Delta clade were identified (Fig. | PMC10655423 |
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Discussion | sudden increase | EVENTS, EVENT, SAID | COVID-19 continues to be a pressing public health problem. Different countries have had varying levels of success in combating the COVID-19 pandemic, with some countries among the most successful in the world at containing the pandemic and others in serious jeopardy. In the East Asia and Pacific regions, the most successful are considered Singapore, New Zealand, South Korea, China, and Vietnam [Genomic surveillance for SARS-CoV-2 was announced by the WHO as a necessary measure for pandemic control. In June 2020, the WHO Virus Evolution Working Group was established with a specific focus on SARS-CoV-2 variants, their phenotype, and their impact on countermeasures [The Pasteur Institute in Ho Chi Minh City has shown vigilance and readiness in terms of monitoring SARS-CoV-2 lineages using NGS methods. According to the data obtained, it can be said that the first imported cases were from China and belonged to 19A (lineage B). Variants of lineage 19B (lineage A) circulated in Southern Vietnam from February to March 2020. In China, lineages A and B circulated together for a short time and were quickly totally replaced by lineage B [In addition to multiple introduced variants in 2020 [The beginning of the pandemic was marked by two major lineages, denoted ‘A’ and ‘B’, which are probably the result of two different spillover events. The first zoonotic transmission likely involved lineage B viruses and occurred from late-November to early-December 2019 (no earlier than early November 2019). Introduction of lineage A likely occurred within weeks of the first event [At the beginning of 2021, the Alpha and Beta variants (20I, 20H) continued circulation in Southern Vietnam. Like global COVID-19 pandemic trends, they were completely replaced by Delta lineages, followed by a sudden increase in incidence marking the beginning of the 4th pandemic wave in Vietnam. The Delta variant was represented by three phylogenetic lineages (21A, 21I, 21J), with the 21I lineage dominating. Intragenomic variability within the Delta lineage was observed as a set of synonymous and non-synonymous substitutions in addition to the defining ones.The first Delta variant sequences available in GISAID for ASEAN countries came from Malaysia [ | PMC10655423 |
Conclusion | Pandemic dynamics in Southern Vietnam feature specific variations in incidence, and these largely reflect the success of the substantial, ongoing restrictive measures put in place during the early stages of the pandemic. Tracking of circulating lineages revealed major variants from the list of variants-of-concern, including intragenomic variability within circulating lineages. Further evaluation of epidemiological features and the circulation of SARS-CoV-2 variants is an essential part of COVID-19 surveillance in Vietnam. | PMC10655423 |
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Acknowledgements | The authors would like to thank: Pham Thi Thu Hang, Vu Pham Hong Nhung, Nguyen Viet Thinh and Luong Chan Quang for their technical and epidemiological data assistance; and the US CDC for reagent support. | PMC10655423 |
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Authors’ contributions | Conceptualization: ASG, TMC, VGD; investigation and methodology: ASG, TMC, EOK, MHD, AAS, VDM, MRP, TVA, VAS, NAT; formal analysis: ASG, TMC, EOK, MHD, AAS, VDM; resources: TMC, VGD; supervision: TMC, VGD; writing – original draft, ASG, TMC, EOK; writing – review & editing, ER. All authors have read and agreed to the final version of the manuscript. | PMC10655423 |
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Funding | The study was funded within the framework of Russian-Vietnamese cooperation in accordance with the Decree of the Government of the Russian Federation of July 13, 2019 (No. 1536-r). | PMC10655423 |
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Availability of data and materials | Genomic consensus sequences obtained in this study are deposited in GISAID ( | PMC10655423 |
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Declarations | PMC10655423 |
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Ethics approval and consent to participate | The study was evaluated and approved by the local Ethics Committee of the St. Petersburg Pasteur Institute (St. Petersburg, Russia, № 063–03) and the Ethics Committee of the Pasteur Institute in Ho Chi Minh City (17/CN-HDDD). Research was performed according to the principles of Declaration of Helsinki for medical research. Informed consent was obtained from all subjects and/or their legal guardian(s). | PMC10655423 |
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Consent for publication | Not applicable. | PMC10655423 |
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Competing interests | The authors declare no competing interests. | PMC10655423 |
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References | PMC10655423 |
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Background | fistula, gastro-cutaneous fistulae | COMPLICATION | Gastro-cutaneous fistula is a rare complication after laparoscopic sleeve gastrectomy (LSG) with incidence of occurrence 1–2%. Most of gastro-cutaneous fistulae do not respond to conservative management and need intervention either surgically or endoscopically.
| PMC10017559 |
Methods | fistula, post-LSG leak or gastro-cutaneous fistula | SECONDARY, RECURRENCE | This prospective randomized clinical study included referred patients who had LSG performed at our department or other centers, and complicated with post-LSG leak or gastro-cutaneous fistula between December/2019 and March/2021. Included patients were ASA Physical status I–II. Primary and secondary outcomes were recurrence of the fistula and mortality in each group after the intervention during the 18 months follow-up period, respectively. | PMC10017559 |
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