Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus

NCT03790579 | Completed

• 1 other identifier: Hacettepe Nutrition
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes, Gestational; Dietary Habits

Keywords

Gestational diabetes mellitus; Dietary acid load; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Dietary acid load

  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.

  24-28. weeks of pregnancy

Study Arms (2)

Women with gestational diabetes

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).

Healthy women

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

Eligibility Criteria

• Age: 21 Years - 41 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Feeding Behavior

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior, Animal; Behavior

Study Officials

• Gülhan SAMUR, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Gözde EDE, MSci

  Mehmet Akif Ersoy University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: December 31, 2018
• Study Start: January 5, 2014
• Primary Completion: September 5, 2014
• Study Completion: October 5, 2014
• Last Updated: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share