Diabetes, Gestational Clinical Trial
Official title:
Lower Vitamin D Levels During Second Trimester Are Associated With Developing Gestational Diabetes Mellitus: an Observational Cross-sectional Study
Verified date | September 2018 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 5, 2013 |
Est. primary completion date | August 5, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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, or - Women receiving drugs related to calcium and vitamin D metabolism (with the exception of routine vitamin supplements prescribed during pregnancy) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hacettepe University |
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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. Review. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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