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

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Gestational diabetes mellitus

oral glucose tolerance test

Time frame: 27-28 weeks of gestation

Secondary Outcomes

insulin resistance

measure of insulin resistance by HOMA-IR, sample of umbilical cord

Time frame: At birth