The Relation Between Vitamin D and Gestational Diabetes Mellitus

NCT03665974 | Completed

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

Brief Summary

Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with the onset or first recognition during pregnancy. The prevalence of GDM varies from 1-14% due to its variability worldwide, depending on the ethnicity, race, and the diagnostic criteria being applied by each country. In addition to this, approximately 7% of all pregnancies are affected by GDM, ending up more than 200,000 women with GDM per year. A recent study of literature research indicated that Middle East and North Africa had the highest prevalence (median, 12.9%) while Europe had the lowest prevalence (median, 5.8%) in the world. In Turkey the prevalence of GDM ranges between 4-10%, based on the reports in different studies. As a growing health concern, GDM has been associated with short and long-term detrimental health outcomes for women and their offspring. Maternal adverse effects of GDM are preeclampsia, elevated risk of development of hypertension, type 2 diabetes mellitus (T2DM), urinary tract infection and comorbidities following delivery. Macrosomia, neonatal jaundice, birth trauma, respiratory distress syndrome, hypoglycemia are included in short term consequence for the neonates whereas risk for development of impaired glucose tolerance, T2DM, obesity, vascular disorders are long term adverse effects on infant's health. The known risk factors for GDM include family history of T2DM, maternal overweight and obesity, advanced maternal age, history of GDM, having macrosomic infant previously, prior fetal death, and race/ethnicity. In addition to these risk factors, recent studies have been suggested that maternal vitamin D deficiency may be associated with a higher risk of GDM. Vitamin D deficiency during the pregnancy has been associated with adverse outcomes for the pregnant women, such as gestational diabetes mellitus, urinary tract infection, preeclampsia, caesarean section during labour \[25\]. Furthermore, infants born to mothers with lower vitamin D levels have been found to be associated with elevated risk of small for gestational age, low birth weight in the neonatal period, increased risk for cardiovascular disease, respiratory illnesses, type 2 diabetes mellitus in childhood and adulthood. The aim of this study was to compare the serum 25(OH)D levels of women with and without gestational diabetes mellitus (GDM) and identify the serum 25(OH)D level associated with GDM during pregnancy.

Conditions

Deficiency, Vitamin D; Diabetes, Gestational

Keywords

Pregnancy, deficinecy, vitamin D, diabetes, gestational

Outcome Measures

Primary Outcomes (2)

• Serum 25(OH)D levels

  Levels of 25(OH)D on serum was measured by high performance liquid chromatography (HPLC) in biochemistry laboratory at Gulhane Education and Research Hospital.

  24-28. weeks of pregnancy

• Pre-pregnancy BMI

  BMI (Body Mass Index) was calculated by using the following formula: BMI=Weight (kg)/\[Height (m) × Height (m)\].

  24-28. weeks of pregnancy

Study Arms (2)

Women with gestational diabetes mellitus

GDM screening at this hospital involves a two-step procedure. 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).

Women non gestational diabetes mellitus

Women with normal serum glucose levels ≤129 mg/dL (7.2 mmol/L) after GCT.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• 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 20-40 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, or
• Women receiving drugs related to calcium and vitamin D metabolism (with the exception of routine vitamin supplements prescribed during pregnancy)

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (14)

• Kennelly MA, McAuliffe FM. Prediction and prevention of Gestational Diabetes: an update of recent literature. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:92-8. doi: 10.1016/j.ejogrb.2016.03.032. Epub 2016 Apr 4.

  PMID: 27235645 BACKGROUND

• Damm P, Houshmand-Oeregaard A, Kelstrup L, Lauenborg J, Mathiesen ER, Clausen TD. Gestational diabetes mellitus and long-term consequences for mother and offspring: a view from Denmark. Diabetologia. 2016 Jul;59(7):1396-1399. doi: 10.1007/s00125-016-3985-5. Epub 2016 May 12.

  PMID: 27174368 BACKGROUND

• Zhang MX, Pan GT, Guo JF, Li BY, Qin LQ, Zhang ZL. Vitamin D Deficiency Increases the Risk of Gestational Diabetes Mellitus: A Meta-Analysis of Observational Studies. Nutrients. 2015 Oct 1;7(10):8366-75. doi: 10.3390/nu7105398.

  PMID: 26437429 BACKGROUND

• Poel YH, Hummel P, Lips P, Stam F, van der Ploeg T, Simsek S. Vitamin D and gestational diabetes: a systematic review and meta-analysis. Eur J Intern Med. 2012 Jul;23(5):465-9. doi: 10.1016/j.ejim.2012.01.007. Epub 2012 Feb 21.

  PMID: 22726378 BACKGROUND

• Burris HH, Rifas-Shiman SL, Kleinman K, Litonjua AA, Huh SY, Rich-Edwards JW, Camargo CA Jr, Gillman MW. Vitamin D deficiency in pregnancy and gestational diabetes mellitus. Am J Obstet Gynecol. 2012 Sep;207(3):182.e1-8. doi: 10.1016/j.ajog.2012.05.022. Epub 2012 Jun 1.

  PMID: 22717271 BACKGROUND

• Mutlu N, Esra H, Begum A, Fatma D, Arzu Y, Yalcin H, Fatih K, Selahattin K. Relation of maternal vitamin D status with gestational diabetes mellitus and perinatal outcome. Afr Health Sci. 2015 Jun;15(2):523-31. doi: 10.4314/ahs.v15i2.27.

  PMID: 26124799 BACKGROUND

• American Diabetes Association. Gestational diabetes mellitus. Diabetes Care. 2004 Jan;27 Suppl 1:S88-90. doi: 10.2337/diacare.27.2007.s88. No abstract available.

  PMID: 14693936 RESULT

• Wei SQ. Vitamin D and pregnancy outcomes. Curr Opin Obstet Gynecol. 2014 Dec;26(6):438-47. doi: 10.1097/GCO.0000000000000117.

  PMID: 25310531 RESULT

• Durnwald C. Gestational diabetes: Linking epidemiology, excessive gestational weight gain, adverse pregnancy outcomes, and future metabolic syndrome. Semin Perinatol. 2015 Jun;39(4):254-8. doi: 10.1053/j.semperi.2015.05.002. Epub 2015 Jun 17.

  PMID: 26093518 RESULT

• Sreelakshmi PR, Nair S, Soman B, Alex R, Vijayakumar K, Kutty VR. Maternal and neonatal outcomes of gestational diabetes: A retrospective cohort study from Southern India. J Family Med Prim Care. 2015 Jul-Sep;4(3):395-8. doi: 10.4103/2249-4863.161331.

  PMID: 26288780 RESULT

• Domaracki P, Sadlecki P, Odrowaz-Sypniewska G, Dzikowska E, Walentowicz P, Siodmiak J, Grabiec M, Walentowicz-Sadlecka M. Serum 25(OH) Vitamin D Levels in Polish Women during Pregnancies Complicated by Hypertensive Disorders and Gestational Diabetes. Int J Mol Sci. 2016 Sep 27;17(10):1574. doi: 10.3390/ijms17101574.

  PMID: 27690002 RESULT

• Lu M, Xu Y, Lv L, Zhang M. Association between vitamin D status and the risk of gestational diabetes mellitus: a meta-analysis. Arch Gynecol Obstet. 2016 May;293(5):959-66. doi: 10.1007/s00404-016-4010-4. Epub 2016 Jan 29.

  PMID: 26825733 RESULT

• Pirjani R, Shirzad N, Qorbani M, Phelpheli M, Nasli-Esfahani E, Bandarian F, Hemmatabadi M. Gestational diabetes mellitus its association with obesity: a prospective cohort study. Eat Weight Disord. 2017 Sep;22(3):445-450. doi: 10.1007/s40519-016-0332-2. Epub 2016 Oct 17.

  PMID: 27747467 RESULT

• Jelsma JG, van Poppel MN, Galjaard S, Desoye G, Corcoy R, Devlieger R, van Assche A, Timmerman D, Jans G, Harreiter J, Kautzky-Willer A, Damm P, Mathiesen ER, Jensen DM, Andersen L, Dunne F, Lapolla A, Di Cianni G, Bertolotto A, Wender-Oegowska E, Zawiejska A, Blumska K, Hill D, Rebollo P, Snoek FJ, Simmons D. DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol. BMC Pregnancy Childbirth. 2013 Jul 5;13:142. doi: 10.1186/1471-2393-13-142.

  PMID: 23829946 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency; Diabetes, Gestational; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gülhan SAMUR, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Gözde EDE, MSci

  Hacettepe University

  STUDY CHAIR

• Müfit YENEN, Professor

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Uğur KESKİN, Assoc. Prof.

  Gulhane Education and Research Hospital

  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: September 6, 2018
• First Posted: September 11, 2018
• Study Start: January 5, 2013
• Primary Completion: August 5, 2013
• Study Completion: August 5, 2013
• Last Updated: September 11, 2018

Record last verified: 2018-09