Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women

Study Overview
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Brief Summary
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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.

Official Title
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EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.

Conditions
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Pregestational Obesity (BMI > 27kg/m2), History of Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: medical nutrition therapy + metformin
* Behavioral: Medical nutrition therapy


Participation Criteria
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Eligibility Criteria
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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 Epilepsy Lupus Chronic hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical nutrition therapy + metformin<br>medical nutrition therapy plus trans-gestational metformin (850mg 2 times day) | Drug: medical nutrition therapy + metformin<br> <br> |
| Active Comparator: medical nutrition therapy<br>medical nutrition therapy without trans-gestational metformin | Behavioral: Medical nutrition therapy<br>* medical nutrition therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes mellitus | oral glucose tolerance test | 27-28 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance | measure of insulin resistance by HOMA-IR, sample of umbilical cord | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, polycystic ovary syndrome, gestational diabetes