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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
Sponsor:
Information provided by (Responsible Party):
F. Gülhan Samur, Hacettepe University

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.


Condition or disease
Deficiency, Vitamin D Diabetes, Gestational

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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)].




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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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, or
  • Women receiving drugs related to calcium and vitamin D metabolism (with the exception of routine vitamin supplements prescribed during pregnancy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665974


Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Gülhan SAMUR, Professor Hacettepe University
Study Chair: Gözde EDE, MSci Hacettepe University
Study Chair: Müfit YENEN, Professor University of Health Sciences
Study Chair: Uğur KESKİN, Assoc. Prof. Gulhane Education and Research Hospital

Publications of Results:

Other Publications:
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Responsible Party: F. Gülhan Samur, Professor doctor, Hacettepe University
ClinicalTrials.gov Identifier: NCT03665974     History of Changes
Other Study ID Numbers: Hacettepe University Nutrition
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by F. Gülhan Samur, Hacettepe University:
Pregnancy, deficinecy, vitamin D, diabetes, gestational

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Avitaminosis
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents