## Protocol Section
### Identification Module
**NCT ID:** NCT03790579

**Brief Title:** Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus

**Official Title:** Is There Any Effect of Maternal Dietary Acid Load During Pregnancy on Arising Gestational Diabetes Mellitus?

#### Organization Study ID Info
**ID:** Hacettepe Nutrition
#### Organization
**Class:** OTHER
**Full Name:** Hacettepe University
### Status Module
#### Completion Date
**Date:** 2014-10-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-02

**Type:** ACTUAL

**Last Update Submit Date:** 2018-12-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-09-05

**Type:** ACTUAL

#### Start Date
**Date:** 2014-01-05

**Type:** ACTUAL

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2018-12-31
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-28
**Study First Submit QC Date:** 2018-12-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hacettepe University

#### Responsible Party

**Investigator Affiliation:** Hacettepe University

**Investigator Full Name:** F. Gülhan Samur

**Investigator Title:** Professor doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Dietary habits resembling Western style, rich in animal protein and poor in fruit and vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the studies related to relationships between dietary acid load and insulin resistance has become a growing interest but there are only a few study conducted with gestational diabetes mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship between dietary acid load in second trimester, blood lipid profiles and GDM.

**Detailed Description:** This cross-sectional study conducted with 40 women with GDM diagnosed with two-step 100g oral glucose tolerance test and 40 healthy women, aged 21-41 years, between weeks of 14-28 of pregnancy, who attended the Department of Obstetrics and Gynecology of Gulhane Training and Research Hospital. Participants with polycystic ovary syndrome, chronic diseases, pre-GDM, or multiple pregnancies were excluded. Sociodemographic information was recorded via questionnaire and anthropometrics of women were measured.

Blood samples were taken after an overnight fasting. Dietary information was obtained by mean intakes of a 3-day food records (2 weekdays and 1 weekend day) and analyzed via nutrition analysis software. According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load. All nutrients were age and energy- adjusted before being introduced into the equation and tertiles of the scores were used for statistical analysis. ANOVA, ANCOVA and Logistic regression test were used. The study plan was approved by the Hospital\&#39;s Ethics Committee.

### Conditions Module

**Conditions:**

- Diabetes, Gestational

- Dietary Habits

**Keywords:**

- Gestational diabetes mellitus

- Dietary acid load

- Pregnancy

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** We randomly selected the 40 pregnant women diagnosed GDM by two-step procedure based on Carpenter-Coustan criteria at this hospital. The diagnosis of GDM was confirmed if at least 2 of 4 glucose levels exceed based on Carpenter-Coustan criteria: fasting ≥ 95 mg/dL (5.3 mmol/L), 1 hour ≥ 180 mg/dL ( 10.0 mmol/L), 2 hour ≥ 155 mg/dL (8.6 mmol/L), and 3 hour ≥ 140 mg/dL (7.8 mmol/L).

**Label:** Women with gestational diabetes

#### Arm Group 2

**Description:** We also randomly selected 40 healthy pregnant with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT.

**Label:** Healthy women

### Outcomes Module

#### Primary Outcomes

**Description:** According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load.

**Measure:** Dietary acid load

**Time Frame:** 24-28. weeks of pregnancy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Singleton pregnancy,
* Aged in 20-40 years,
* Gestational age 24-28 weeks,
* Non-history of acute or chronic diseases.

Exclusion Criteria:

* History of GDM,
* Type 1 and 2 diabetes mellitus,
* Preeclampsia,
* Polycystic ovary syndrome,
* Thyroid disease
* Parathyroid disease,
* Metabolic bone disease,
* Kidney disease,
* Abnormal liver function,
* Multiple pregnancy
* Extreme values of energy intake in their dietary records (\<1500 and \>4000 kkal).

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 41 Years

**Minimum Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant between 21-41 years in age, in their 24-28th gestational week applied to Gulhane Education and Research Hospital were recruited. This study must recruit 40 women for each group to have 80% study power with 5% type I error level to detect a clinically significant difference.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Hacettepe University

**Name:** Gülhan SAMUR, Professor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Mehmet Akif Ersoy University

**Name:** Gözde EDE, MSci

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Della Guardia L, Thomas MA, Cena H. Insulin Sensitivity and Glucose Homeostasis Can Be Influenced by Metabolic Acid Load. Nutrients. 2018 May 15;10(5):618. doi: 10.3390/nu10050618.

**PMID:** 29762478

**Citation:** Jayedi A, Shab-Bidar S. Dietary acid load and risk of type 2 diabetes: A systematic review and dose-response meta-analysis of prospective observational studies. Clin Nutr ESPEN. 2018 Feb;23:10-18. doi: 10.1016/j.clnesp.2017.12.005. Epub 2017 Dec 23.

**PMID:** 29460782

**Citation:** Williams RS, Kozan P, Samocha-Bonet D. The role of dietary acid load and mild metabolic acidosis in insulin resistance in humans. Biochimie. 2016 May;124:171-177. doi: 10.1016/j.biochi.2015.09.012. Epub 2015 Sep 10.

**PMID:** 26363101

**Citation:** Gaede J, Nielsen T, Madsen ML, Toft U, Jorgensen T, Overvad K, Tjonneland A, Hansen T, Allin KH, Pedersen O. Population-based studies of relationships between dietary acidity load, insulin resistance and incident diabetes in Danes. Nutr J. 2018 Oct 6;17(1):91. doi: 10.1186/s12937-018-0395-1.

**PMID:** 30292239

**Citation:** Saraf-Bank S, Tehrani H, Haghighatdoost F, Moosavian SP, Azadbakht L. The acidity of early pregnancy diet and risk of gestational diabetes mellitus. Clin Nutr. 2018 Dec;37(6 Pt A):2054-2059. doi: 10.1016/j.clnu.2017.09.020. Epub 2017 Oct 3.

**PMID:** 29054469

**Citation:** Miki A, Hashimoto Y, Tanaka M, Kobayashi Y, Wada S, Kuwahata M, Kido Y, Yamazaki M, Fukui M. Urinary pH reflects dietary acid load in patients with type 2 diabetes. J Clin Biochem Nutr. 2017 Jul;61(1):74-77. doi: 10.3164/jcbn.16-118. Epub 2017 Jul 1.

**PMID:** 28751813

**Citation:** Kiefte-de Jong JC, Li Y, Chen M, Curhan GC, Mattei J, Malik VS, Forman JP, Franco OH, Hu FB. Diet-dependent acid load and type 2 diabetes: pooled results from three prospective cohort studies. Diabetologia. 2017 Feb;60(2):270-279. doi: 10.1007/s00125-016-4153-7. Epub 2016 Nov 17.

**PMID:** 27858141

**Citation:** Williams RS, Heilbronn LK, Chen DL, Coster AC, Greenfield JR, Samocha-Bonet D. Dietary acid load, metabolic acidosis and insulin resistance - Lessons from cross-sectional and overfeeding studies in humans. Clin Nutr. 2016 Oct;35(5):1084-90. doi: 10.1016/j.clnu.2015.08.002. Epub 2015 Aug 12.

**PMID:** 26299332

**Citation:** Akter S, Eguchi M, Kuwahara K, Kochi T, Ito R, Kurotani K, Tsuruoka H, Nanri A, Kabe I, Mizoue T. High dietary acid load is associated with insulin resistance: The Furukawa Nutrition and Health Study. Clin Nutr. 2016 Apr;35(2):453-459. doi: 10.1016/j.clnu.2015.03.008. Epub 2015 Mar 27.

**PMID:** 25863769

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: HIGH

- As Found: Gestational Diabetes Mellitus

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016640

- Term: Diabetes, Gestational

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-24
