Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01675310|
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregestational Obesity (BMI > 27kg/m2) History of Polycystic Ovary Syndrome||Drug: medical nutrition therapy + metformin Behavioral: Medical nutrition therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||March 2015|
U.S. FDA Resources
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
- 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
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): NCT01675310
|National Institute of Perinatology|
|Mexico, Mexico, 11000|
|Principal Investigator:||Enrique Reyes-Muñoz, PhD||National Institute of Perinatology, Mexico City|