The Relation Between Vitamin D and Gestational Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT03665974|
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
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 . 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.
|Condition or disease|
|Deficiency, Vitamin D Diabetes, Gestational|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Lower Vitamin D Levels During Second Trimester Are Associated With Developing Gestational Diabetes Mellitus: an Observational Cross-sectional Study|
|Actual Study Start Date :||January 5, 2013|
|Actual Primary Completion Date :||August 5, 2013|
|Actual Study Completion Date :||August 5, 2013|
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.
- Serum 25(OH)D levels [ Time Frame: 24-28. weeks of pregnancy ]Levels of 25(OH)D on serum was measured by high performance liquid chromatography (HPLC) in biochemistry laboratory at Gulhane Education and Research Hospital.
- Pre-pregnancy BMI [ Time Frame: 24-28. weeks of pregnancy ]
BMI (Body Mass Index) was calculated by using the following formula:
BMI=Weight (kg)/[Height (m) × Height (m)].
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665974
|Principal Investigator:||Gülhan SAMUR, Professor||Hacettepe University|
|Study Chair:||Gözde EDE, MSci||Hacettepe University|
|Study Chair:||Müfit YENEN, Professor||Saglik Bilimleri Universitesi|
|Study Chair:||Uğur KESKİN, Assoc. Prof.||Gulhane Education and Research Hospital|