title: Risk factors of one year increment of coronary calcifications and survival in hemodialysis patients The effect of calcium and vitamin D supplementation on obesity in postmenopausal women: secondary analysis for a large-scale, placebo controlled, double-blind, 4-year longitudinal clinical trial The effect of cholecalciferol supplementation on vitamin D levels and insulin sensitivity is dose related in vitamin D-deficient HIV-1-infected patients. Leptin administered in physiological or pharmacological doses does not regulate circulating angiogenesis factors in humans Effect of adiposity on vitamin D status and the 25-hydroxycholecalciferol response to supplementation in healthy young and older Irish adults. Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial. Vitamin D deficiency, serum leptin and osteoprotegerin levels in older diabetic patients: an input to new research avenues Calcium-vitamin D cosupplementation influences circulating inflammatory biomarkers and adipocytokines in vitamin D-insufficient diabetics: a randomized controlled clinical trial. The Effect of Vitamin D Supplementation on Adiposity, Blood Glycated Hemoglobin, Serum Leptin and Tumor Necrosis Factor-α in Type 2 Diabetic Patients The relationship between adipokines, osteocalcin and bone quality in chronic kidney disease. Effect of high doses of vitamin D on arterial properties, adiponectin, leptin and glucose homeostasis in type 2 diabetic patients. Vitamin D improves endothelial function in patients with Type 2 diabetes mellitus and low vitamin D levels. Cross-sectional and longitudinal relation between serum 25-hydroxyvitamin D and body mass index: the Tromsø study Effect of vitamin D deficiency and replacement on endothelial function in asymptomatic subjects. Bone Remodeling, Bone Mass and Weight Gain in Patients with Stabilized Schizophrenia in Real-Life Conditions Treated with Long-Acting Injectable Risperidone
abstract: Background Heart and coronary calcifications in hemodialysis patients are of very common occurrence and linked to cardiovascular events and mortality . Several studies have been published with similar results . Most of them were mainly cross-sectional and some of the prospect i ve protocol s were aim ed to evaluate the results of the control of altered biochemical parameters of mineral disturbances with special regard to serum calcium , phosphate and CaxP with the use of calcium containing and calcium free phosphate chelating agents . The aim of the present study was to evaluate in hemodialysis patients classic and some non classic risk factors as predictors of calcification changes after one year and to evaluate the impact of progression on survival . Methods 81 patients on hemodialysis were studied , with a wide age range and HD vintage . Several classic parameters and some less classic risk factors were studied like fetuin-A , CRP , 25-OHD and leptin . Calcifications , as Agatston scores , were evaluated with Multislice CT basally and after 12 - 18 months . Results Coronary artery calcifications were observed in 71 of 81 patients . Non parametric correlations between Agatston scores and Age , HD Age , PTH and CRP were significant . Delta increments of Agatston scores correlated also with serum calcium , CaxP , Fetuin-A , triglycerides and serum albumin . Logistic regression analysis showed Age , PTH and serum calcium as important predictors of Delta Agatston scores . LN transformation of the not normally distributed variables restricted the significant correlations to Age , BMI and CRP . Considering the Delta Agatston scores as dependent , significant predictors were Age , PTH and HDL . A strong association was found between basal calcification scores and Delta increment at one year . By logistic analysis , the one year increments in Agatston scores were found to be predictors of mortality .  Diabetic and hypertensive patients have significantly higher Delta scores . Conclusions Progression of calcification is of common occurrence , with special regard to elevated basal scores , and is predictive of survival . Higher predictive value of survival is linked to the one year increment of calcification scores . Some classic and non classic risk factors play an important role in progression . Some of them could be controlled with appropriate management with possible improvement of mortality Background It is undetermined whether calcium supplementation has an effect on obesity or body composition in postmenopausal women . The purpose of the study is to detect the effect of calcium supplementation on indices of obesity and body composition . Methods This is a secondary analysis of data from a population -based , double-blind , placebo-controlled , r and omized trial design ed to determine the effects of calcium and vitamin D on osteoporotic fractures . The cohort included 1179 postmenopausal women who were r and omly assigned into one of three groups : 1 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus vitamin D placebo ( Ca-only group ) ; 2 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus supplemental vitamin D3 ( 1100 IU/d ) ( Ca + D group ) ; or , 3 ) two placebos ( placebo group ) . After applying the exclusion criteria for this analysis , 870 subjects were included in this study . The primary outcomes for the present study were changes in body mass index , trunk fat , trunk lean , and percentage of trunk fat after calcium supplementation . Results Changes in trunk fat , trunk lean , and percentage of trunk fat were significantly different between the calcium intervention groups ( Ca-only group or Ca + D group ) and the placebo group during the trial ( P < 0.05 ) . The calcium intervention groups gained less trunk fat and maintained more trunk lean when compared to the placebo group . No significant difference was observed for body mass index between groups . Conclusion Calcium supplementation over four years has a beneficial effect on body composition in postmenopausal women OBJECTIVE The aim of this study was to explore the effects of cholecalciferol supplementation on vitamin D levels , bone mineral density ( BMD ) , body fat distribution and insulin sensitivity in vitamin D-deficient HIV-1-infected patients . METHODS Twenty vitamin D-deficient HIV-1-infected patients were prospect ively treated with 2000 IU cholecalciferol/day for 14 weeks , whereafter treatment was continued with half this dosage until 48 weeks . BMD , body fat distribution , 1,25-dihydroxy vitamin D(3 ) ( 1,25(OH)2D3 ) , fasting glucose , insulin , adiponectin , leptin , interleukin (IL)-6 and tumour necrosis factor (TNF)-alpha were measured at baseline , and at 24 and 48 weeks . Parathyroid hormone ( PTH ) , 25-hydroxy vitamin D(3 ) [ 25(OH)D(3 ) ] , cholesterol and triglycerides were measured at baseline , and at 12 , 24 and 48 weeks . RESULTS After 24 weeks , cholecalciferol supplementation significantly increased 25(OH)D3 and 1,25(OH)2D3 levels and decreased PTH and insulin sensitivity . After 48 weeks , however , only 25(OH)D3 levels remained significantly different from baseline , while the other parameter levels returned to baseline , suggesting a dose-response effect . Cholecalciferol had no effect on BMD , adipokines and triglycerides . CONCLUSIONS The effect of cholecalciferol treatment in this cohort appears to be dose dependent . Cholecalciferol dosages of > or = 2000 IU are necessary to achieve 1,25(OH)2D3 levels that significantly decrease PTH , but also negatively affect insulin sensitivity . The results of this hypothesis-driven explorative study need to be confirmed in larger clinical trials Aim /hypothesisLeptin has been shown to regulate angiogenesis in animal and in vitro studies by upregulating the production of several pro-angiogenic factors , but its role in regulating angiogenesis has never been studied in humans . Methods The potential angiogenic effect of two doses of metreleptin ( 50 and 100 ng/ml ) was evaluated in vitro , using a novel three-dimensional angiogenesis assay . Fifteen healthy , normoleptinaemic volunteers were administered both a physiological ( 0.1 mg/kg ) and a pharmacological ( 0.3 mg/kg ) single dose of metreleptin , in vivo , on two different inpatient admissions separated by 1–12 weeks . Serum was collected at 0 , 6 , 12 and 24 h after metreleptin administration . Twenty lean women , with leptin levels < 5 ng/ml , were r and omised in a 1:1 fashion to receive either physiological replacement doses of metreleptin ( 0.04–0.12 mg/kg q.d . ) or placebo for 32 weeks . Serum was collected at 0 , 8 , 20 and 32 weeks after r and omisation . Proteomic angiogenesis array analysis was performed to screen for angiogenic factors . Circulating concentrations of angiogenin , angiopoietin-1 , platelet derived endothelial factor (PDGF)-AA , matrix metalloproteinase ( MMP ) 8 and 9 , endothelial growth factor ( EGF ) and vascular EGF ( VEGF ) were also measured . Results Both metreleptin doses failed to induce angiogenesis in the in vitro model . Although leptin levels increased significantly in response to both short-term and long-term metreleptin administration , circulating concentrations of angiogenesis markers did not change significantly in vivo . Conclusions /interpretationsThis is the first study that examines the effect of metreleptin administration in angiogenesis in humans . Metreleptin administration does not regulate circulating angiogenesis related factors in humans . Clinical trial registration : Clinical Trials.gov NCT00140205 and NCT00130117 . Funding : This study was supported by National Institutes of Health-National Center for Research Re sources grant M01-RR-01032 ( Harvard Clinical and Translational Science Center ) and grant number UL1 RR025758 . Funding was also received from the National Institute of Diabetes and Digestive and Kidney Diseases grants 58785 , 79929 and 81913 , and AG032030 There is increasing epidemiological evidence linking sub-optimal vitamin D status with overweight and obesity . Although increasing BMI and adiposity have also been negatively associated with the change in vitamin D status following supplementation , results have been equivocal . The aim of this r and omised , placebo-controlled study was to investigate the associations between anthropometric measures of adiposity and the wintertime serum 25-hydroxycholecalciferol ( 25(OH)D ) response to 15 μg cholecalciferol per d in healthy young and older Irish adults . A total of 110 young adults ( 20 - 40 years ) and 102 older adults ( ≥ 64 years ) completed the 22-week intervention with > 85 % compliance . The change in 25(OH)D from baseline was calculated . Anthropometric measures of adiposity taken at baseline included height , weight and waist circumference ( WC ) , along with skinfold thickness measurements to estimate fat mass ( FM ) . FM was subsequently expressed as FM ( kg ) , FM ( % ) , FM index ( FMI ( FM kg/height m2 ) ) and as a percentage ratio to fat-free mass ( FFM ) . In older adults , vitamin D status was inversely associated with BMI ( kg/m2 ) , WC ( cm ) , FM ( kg and % ) , FMI ( kg/m2 ) and FM : FFM ( % ) at baseline ( r - 0·33 , - 0·36 , - 0·33 , - 0·30 , - 0·33 and - 0·27 , respectively , all P values < 0·01 ) . BMI in older adults was also negatively associated with the change in 25(OH)D  following supplementation ( β - 1·27 , CI - 2·37 , - 0·16 , P = 0·026 ) ; however , no such associations were apparent in younger adults . Results suggest that adiposity may need to be taken into account when determining an adequate wintertime dietary vitamin D intake for healthy older adults residing at higher latitudes Observational studies have suggested that 25-hydroxyvitamin D ( 25(OH)D ) levels are associated with inflammatory markers . Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups . Thus , we aim ed to determine the effect of supplementary vitamin D using secondary data from a population -based , r and omised , placebo-controlled , double-blind trial ( Pilot D-Health trial 2010/0423 ) . Participants were 60- to 84-year-old residents of one of the four eastern states of Australia . They were r and omly selected from the electoral roll and were r and omised to one of three trial arms : placebo ( n 214 ) , 750 μg ( n 215 ) or 1500 μg ( n 215 ) vitamin D3 , each taken once per month for 12 months . Post-intervention blood sample s for the analysis of C-reactive protein ( CRP ) , IL-6 , IL-10 , leptin and adiponectin levels were available for 613 participants . Associations between intervention group and biomarker levels were evaluated using quantile regression . There were no statistically significant differences in distributions of CRP , leptin , adiponectin , leptin : adiponectin ratio or IL-10 levels between the placebo group and either supplemented group . The 75th percentile IL-6 level was 2·8 pg/ml higher ( 95 % CI 0·4 , 5·8 pg/ml ) in the 1500 μg group than in the placebo group ( 75th percentiles:11·0 v. 8·2 pg/ml ) , with a somewhat smaller , non-significant difference in 75th percentiles between the 750 μg and placebo groups . Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation , we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels , with the possible exception of IL-6 The aim of this study was to assess the effects of single oral bolus of 300,000 IU Vitamin D3 on serum levels and on bone and metabolic parameters in diabetic patients . This study is a Phase IV , r and omized , double-blind , placebo-controlled , monocenter clinical trial . Thirty patients , 60 years or older , with type 2 diabetes mellitus , and diabetic foot complications , were enrolled and monitored for 24 weeks : 14 were treated with Vitamin D3 and 16 with placebo . Parameters including glucose , adiponectin , leptin , osteoprotegerin ( OPG ) , 25-hydroxyvitamin D [ 25(OH)D ] , beta-CrossLaps , osteocalcin , bone-specific isoenzyme of alkaline phosphatase , tumor necrosis factor-α and parathyroid hormone were measured at screening and baseline and 12 and 24 weeks after treatment . Analysis of covariance was used to compare treatment groups . Analysis of the data detected a significant increase in 25(OH)D serum levels both at 12 and 24 weeks with respect to baseline values only in the treated patients . Significant variations with respect to baseline values were noted in OPG ( P = 0.0085 ) and in leptin ( P = 0.0442 ) levels : these were lower in the placebo group at week 24 but higher in the treated group . Vitamin D3 supplementation significantly increased serum leptin and OPG levels . Further , large-scale clinical trials are warranted to confirm these results CONTEXT To the best of our knowledge , no study has examined the effects of vitamin D-calcium cosupplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient type 2 diabetics . OBJECTIVE This study was performed to assess the effects of vitamin D and calcium supplementation on inflammatory biomarkers and adipocytokines in vitamin D-insufficient people with type 2 diabetes . METHODS Totally , 118 diabetic patients were enrolled in this r and omized , placebo-controlled clinical trial . After matching for age , sex , body mass index , type and dose of hypoglycemic agents , and duration of diabetes , subjects were r and omly assigned into 4 groups receiving the following : 1 ) 50000 IU/wk vitamin D + calcium placebo ; 2 ) 1000 mg/d calcium + vitamin D placebo ; 3 ) 50 000 IU/wk vitamin D + 1000 mg/d calcium ; or 4 ) vitamin D placebo + calcium placebo for 8 weeks . Blood sampling was done for the quantification of inflammatory biomarkers and adipocytokines at the study baseline and after 8 weeks of intervention . RESULTS Calcium ( changes from baseline : -75 ± 19 ng/ml , P = .01 ) and vitamin D alone ( -56 ± 19 ng/mL , P = .01 ) and joint calcium-vitamin D supplementation ( -92 ± 19 ng/mL , P = .01 ) result ed in a significant reduction in serum leptin levels compared with placebo ( -9 ± 18 ng/mL ) . This was also the case for serum IL-6 , such that calcium ( -2 ± 1 pg/mL , P < .001 ) and vitamin D alone ( -4 ± 1 pg/mL , P < .001 ) and their combination ( -4 ± 1 pg/mL , P < .001 ) led to significant reductions compared with placebo ( 3 ± 1 pg/mL ) . After adjustment for potential confounders , individuals in the calcium ( -3.1 ± 1.3 , P < .05 ) , vitamin D ( -3.1 ± 1.3 , P < .05 ) , and joint calcium-vitamin D groups ( -3.4 ± 1.3 , P < .05 ) had greater reductions in serum TNF-α concentrations compared with placebo ( 0.1 ± 1.2 ) . Individuals who received joint calcium-vitamin D supplements tended to have a decrease in serum high-sensitivity C-reactive protein levels compared with placebo after controlling for baseline levels ( -1.14 ± 0.25 vs 0.02 ± 0.24 ng/mL , P = .09 ) . CONCLUSION Joint calcium-vitamin D supplementation might improve systemic inflammation through decreasing IL-6 and TNF-α concentrations in vitamin D-insufficient people with type 2 diabetes Background : Since tumor necrosis factor-α ( TNF-α ) could be one of the risk factors at the development of diabetes complications ; as well as serum leptin deficiency is related to increased susceptibility to infections in diabetic patients , they are potential indices from the preventive medicine viewpoint . This study was conducted to represent the effect of supplemental vitamin D3 on serum leptin , TNF-α and adiposity in type 2 diabetic patients . Methods : In this r and omized double-blind placebo-controlled trial , study sample was selected through type 2 diabetic patients ( n = 51 ) . A total of 26 patients were orally supplemented by vitamin D3 ( 400 IU/d ) ( vitamin D group ) and 25 patients by placebo ( placebo group ) for 14 weeks . The blood glycated hemoglobin ( HbA1c ) and the serum ionized Ca , leptin , TNF-α , and serum 25-hydroxyvitamin D ( 25[OH ] D ) were measured at the two groups in the baseline and postintervention stages . Results : It was shown that despite of theplacebo group , serum 25(OH ) D and serum leptin was significantly increased ( P = 0.001 and P = 0.002 , respectively ) , while serum TNF-α was decreased significantly ( P = 0.001 ) in vitamin D group . The remaining parameters , including body fat mass and HbA1c had no alterations between baseline and postintervention stages in vitamin D group . Conclusions : This study may advocate vitamin D supplementation among type 2 diabetic patients due to its beneficial effects on prevention of diabetes complications OBJECTIVES Osteocalcin , a small peptide secreted by osteoblasts , has been recently described as a circulating hormone involved in the regulation of energy metabolism . In addition , experimental data suggest a regulation of adipocytes by bone , with a stimulation of adiponectin synthesis by osteocalcin and an inverse relationship between serum adiponectin level and bone mineral density ( BMD ) . However , this relationship has not been explored during chronic kidney disease ( CKD ) . METHODS  Osteocalcin , adiponectin and leptin  were prospect ively measured in a cohort of 61 CKD patients . A new non-invasive 3D bone imaging technique was performed ( high-resolution peripheral quantitative computed tomography , HR-pQCT ) , measuring volumetric BMD ( vBMD ) and microarchitecture parameters at the distal tibia . RESULTS Patients ' mean age was 67.2 + /- 13.9 years and mean GFR 33 + /- 12 mL/min/1.73 m(2 ) . We found a positive association between serum osteocalcin and adiponectin ( r = 0.29 , P = 0.021 ) . Univariate analysis showed inverse correlations between serum adiponectin and total vBMD ( r = -0.33 , P = 0.01 ) , cortical thickness ( r = -0.34 , P = 0.008 ) and trabecular vBMD ( r = -0.27 , P = 0.04 ) . These associations remained significant in multivariate analysis between serum adiponectin and total vBMD , cortical vBMD and cortical thickness . CONCLUSION We report for the first time an inverse relationship between bone density and adiponectin , as well as a positive association between osteocalcin and adiponectin in CKD II-IV patients BACKGROUND & AIMS Vitamin D supplementation has the potential to alleviate the cardiovascular damage in diabetic patients . The present study was design ed to evaluate long term impact of high doses of vitamin D on arterial properties , glucose homeostasis , adiponectin and leptin in patients with type 2 diabetes mellitus . METHODS AND RESULTS In r and omized , placebo-controlled study 47 diabetic patients were assigned into two groups : Group 1 received oral daily supplementation with vitamin D at a dose of 1000 U/day for 12 months . Group 2 received matching placebo capsules . Blood sampling for metabolic parameters , including fasting glucose , lipid profile , HbA1C , insulin , hs-CRP , 25 OH Vit D , adiponectin and leptin was performed at baseline and at the end of the study . Insulin resistance was assessed by homeostasis model assessment ( HOMA-IR ) . Central aortic augmentation index ( AI ) was evaluated using SphygmoCor . RESULTS The two groups were similar at baseline in terms of hemodynamic parameters . After 12 months , AI decreased significantly during the treatment period in patients received vitamin D ( p < 0.0001 ) and did not change in placebo group . Glucose homeostasis parameters , leptin as well as leptin adiponectin ratio did not change in both groups . 25 OH Vit D level significantly increased ( p = 0.022 ) and circulating adiponectin marginally increased ( p = 0.065 ) during 12 month treatment period in active treatment and did not change in placebo group . CONCLUSIONS High doses of  vitamin D supplementation in diabetic patients was associated with significant decrease in AI during one year treatment . This beneficial vascular effect was not associated with improvement in glucose homeostasis parameters AIMS To test whether a single large dose of vitamin D2 can improve endothelial function in patients with Type 2 diabetes mellitus and low serum 25-hydroxyvitamin D levels . METHODS Double-blind , parallel group , placebo-controlled r and omized trial . A single dose of 100,000 IU vitamin D2 or placebo was administered to patients with Type 2 diabetes over the winter , when levels of circulating 25-hydroxyvitamin D were likely to be lowest . Patients were enrolled if their baseline 25-hydroxyvitamin D level was < 50 nmol/l .  Endothelial function and blood pressure were measured and fasting blood sample s were taken at baseline and 8 weeks after administration of vitamin D. RESULTS Forty-nine per cent of subjects screened had 25-hydroxyvitamin D levels < 50 nmol/l . Thirty-four subjects completed the study , with a mean age of 64 years and a baseline 25-hydroxyvitamin D level of 38.3 nmol/l .  Vitamin D supplementation  increased 25-hydroxyvitamin D levels by 15.3 nmol/l relative to placebo and significantly improved flow mediated vasodilatation ( FMD ) of the brachial artery by 2.3 % . The improvement in FMD remained significant after adjusting for changes in blood pressure .  Vitamin D supplementation significantly decreased systolic blood pressure by 14 mmHg compared with placebo ; this did not correlate with change in FMD . CONCLUSIONS Vitamin D insufficiency is common in patients with Type 2 diabetes during winter in Scotl and . A single large dose of oral vitamin D2 improves endothelial function in patients with Type 2 diabetes and vitamin D insufficiency Purpose The serum 25-hydroxyvitamin D ( 25(OH)D ) levels are lower in obese than lean subjects . The present study examines the cross-sectional and longitudinal relations between body mass index ( BMI ) and serum 25(OH)D , and the serum 25(OH)D response to vitamin D supplementation  in relation to BMI . Methods The Tromsø study is a longitudinal population -based multi purpose study . The fourth survey was conducted in 1994 and the sixth in 2008 . The intervention study was a 1-year placebo-controlled r and omized intervention trial , where the results from the 93 subjects given 40,000 IU per week are presented . Results A total of 10,229 subjects were included in the 2008 cross-sectional study . There was a significant negative association between serum 25(OH)D levels and BMI which was also present during the winter months . Serum 25(OH)D levels varied through seasons , but not BMI . In the longitudinal study from 1994 to 2008 which included 2,656 subjects , change in BMI was a significant negative predictor of change in 25(OH)D. In the intervention study , there was a significant and negative correlation between BMI and serum 25(OH)D both at baseline and at the end of the study . The increase in serum 25(OH)D after 1 year was significantly and inversely related to baseline BMI . Conclusions We have confirmed the strong association between serum 25(OH)D and BMI . The very obese need higher vitamin D doses than lean subjects to achieve the same serum 25(OH)D levels CONTEXT Vitamin D receptors are present in many tissues . Hypovitaminosis D is considered to be a risk factor for atherosclerosis . OBJECTIVE This study explores the effects of vitamin D replacement on insulin sensitivity , endothelial function , inflammation , oxidative stress , and leptin in vitamin D-deficient subjects . DESIGN , SETTING , AND PATIENTS Twenty-three asymptomatic vitamin D-deficient subjects with 25-hydroxyvitamin D [ 25(OH)D ] levels below 25 nmol/liter were compared with a control group that had a mean 25(OH)D level of 75 nmol/liter . The vitamin D-deficient group received 300,000 IU i m monthly for 3 months . The following parameters were evaluated before and after treatment : vitamin D metabolites , leptin , endothelial function by brachial artery flow mediated dilatation ( FMD ) , insulin sensitivity index based on oral glucose tolerance test , and lipid peroxidation as measures of thiobarbituric acid reactive substances ( TBARS ) . RESULTS FMD measurements were significantly lower in 25(OH)D-deficient subjects than controls ( P = 0.001 ) and improved after replacement therapy ( P = 0.002 ) . Posttreatment values of TBARS were significantly lower than pretreatment levels ( P < 0.001 ) . A positive correlation between FMD and 25(OH)D ( r = 0.45 ; P = 0.001 ) and a negative correlation between FMD and TBARS ( r = -0.28 ; P < 0.05 ) were observed . There was a significant increase in leptin levels after therapy , and the leptin levels were positively correlated with 25(OH)D levels ( r = 0.45 ; P < 0.05 ) . CONCLUSIONS This study shows that 25(OH)D deficiency is associated with endothelial dysfunction and increased lipid peroxidation . Replacement of vitamin D has favorable effects on endothelial function . Vitamin D deficiency can be seen as an independent risk factor of atherosclerosis . Hypovitaminosis D-associated endothelial dysfunction may predispose to higher rates of cardiovascular disease in the winter Background : Prolactin-raising antipsychotics , risperidone ( antidopaminergic activity ) , may be associated with low bone mass . On the other h and , risperidone may cause an increase in body weight thought to be favorable for bone . Objectives : ( 1 ) To determine bone remodeling parameters and bone mass in patients with schizophrenia on long-term treatment with long-acting injectable risperidone ( LAIR ) in naturalistic setting s , and ( 2 ) to evaluate the change in body weight , metabolic profile and neuroendocrine status in these patients . Design : This was a prospect i ve , cross-sectional study . Patients : Patients included 26 out patients with controlled schizophrenia in real-life conditions ( age 31.3 ± 1.3 years , BMI 28.1 ± 1.0 ) on long-term maintenance therapy with LAIR for a mean of 18.0 ± 1.6 months ( range 6–36 ) with a mean dose of 38 ± 2 mg . 35 subjects matched for sex , age , BMI and education served as healthy controls . Methods : Serum osteocalcin , C-terminal telopeptide of type I collagen ( CTx ) , vitamin D , leptin , prolactin , sex steroids , and parathyroid hormone were assessed . Indices of insulin sensitivity and resistance were determined following an oral glucose tolerance test ( OGTT ) . Bone mineral density ( BMD ) was measured by dual X-ray absorptiometry at the lumbar spine ( LS ) and femoral neck ( FN ) . Results : Mild to moderate hyperprolactinemia ( 1,000–2,000 mU/l ) was associated with asymptomatic hypogonadism . Prolactin values > 2,000 mU/l occurred in a few female patients . Hypogonadism leads to a slight increase ( upper limit of normal ) in bone resorption marker ( CTx ) in patients with schizophrenia ( p = 0.023 ) . As for bone mass , although lower at the spine than in healthy subjects , it did not reach statistical significance ( p = 0.094 ) , while at the FN , BMD was not different from healthy subjects . Body weight increased on average 8.7 ± 1.6 kg in more than 50 % of patients . Leptin levels adjusted for BMI in females were significantly higher in patients than in healthy female subjects ( p = 0.018 ) , while in males there was no difference between the groups ( p = 0.833 ) . A high prevalence of low vitamin D levels and more current smokers were found in patients with schizophrenia . As for the metabolic profile during treatment with risperidone , the low Matsuda index of insulin sensitivity ( p = 0.039 ) confirmed insulin resistance in these patients . Conclusion : A potential long-term consequence of asymptomatic hypogonadism due to risperidone-induced hyperprolactinemia might cause a slight rise in bone resorption marker ( CTx ) . On the other h and , by increasing body weight , risperidone could have a protective effect on the bone and thus no change in bone mass was recorded when compared with healthy controls
target: Current evidence indicates that inverse association between leptin level and 25(OH)D concentration was observed in observational studies , which was not demonstrated in intervention studies with high heterogeneity .
background: We aim ed to investigate the potential association between vitamin D and serum leptin levels by pooling together the results from observational studies and clinical trials .