Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
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.
|Pregestational Obesity (BMI > 27kg/m2) History of Polycystic Ovary Syndrome||Drug: medical nutrition therapy + metformin Behavioral: Medical nutrition therapy||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.|
- Gestational diabetes mellitus [ Time Frame: 27-28 weeks of gestation ]oral glucose tolerance test
- insulin resistance [ Time Frame: At birth ]measure of insulin resistance by HOMA-IR, sample of umbilical cord
|Study Start Date:||January 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: medical nutrition therapy + metformin
medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
|Drug: medical nutrition therapy + metformin|
Active Comparator: medical nutrition therapy
medical nutrition therapy without trans-gestational metformin
Behavioral: Medical nutrition therapy
medical nutrition therapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675310
|National Institute of Perinatology|
|Mexico, Mexico, 11000|
|Principal Investigator:||Enrique Reyes-Muñoz, PhD||National Institute of Perinatology, Mexico City|