EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Overview
- Phase
- Phase 4
- Intervention
- medical nutrition therapy + metformin
- Conditions
- Pregestational Obesity (BMI > 27kg/m2)
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Gestational diabetes mellitus
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.
There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.
Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.
Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.
Investigators
ENRIQUE REYES-Munoz MD
Clinical Reseach
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Eligibility Criteria
Inclusion Criteria
- •Mexican women with pregnancy \< 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
- •Body mass index \> 27 kg/m2
- •Maternal age \>25
- •History of infertility with polycystic ovary syndrome
- •History of macrosomic newborn (Weight \>4000g)
- •History of diabetes mellitus in first or second degree.
- •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
- •Chronic hypertension.
Arms & Interventions
medical nutrition therapy + metformin
medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
Intervention: medical nutrition therapy + metformin
medical nutrition therapy
medical nutrition therapy without trans-gestational metformin
Intervention: Medical nutrition therapy
Outcomes
Primary Outcomes
Gestational diabetes mellitus
Time Frame: 27-28 weeks of gestation
oral glucose tolerance test
Secondary Outcomes
- insulin resistance(At birth)