Trial Information
EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Inclusion Criteria:
- Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance
75g-2h test and 3 or more criteria:
1. Body mass index > 27 kg/m2
2. Maternal age >25
3. History of infertility with polycystic ovary syndrome
4. History of macrosomic newborn (Weight >4000g)
5. History of diabetes mellitus in first or second degree.
6. History of gestational diabetes in previous pregnancy
Exclusion Criteria:
- Any form of pregestational diabetes
- Fasting glucose > 126 mg/dL at first prenatal visit.
- seric creatinine > 1.5 mg/dL
- Hyperthyroidism
- Heart disease
- Hepatic disease
- Renal diseases
- Epilepsy
- Lupus
- Chronic hypertension.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Gestational diabetes mellitus
Outcome Description:
oral glucose tolerance test
Outcome Time Frame:
27-28 weeks of gestation
Safety Issue:
No
Authority:
Mexico: Institutional Review Board National Institute of Perinatology
Study ID:
Conacyt 151819
NCT ID:
NCT01675310
Start Date:
October 2011
Completion Date:
January 2014
Related Keywords:
- Pregestational Obesity (BMI > 27kg/m2)
- History of Polycystic Ovary Syndrome
- obesity, polycystic ovary syndrome, gestational diabetes
- Obesity
- Polycystic Ovary Syndrome
- Diabetes, Gestational