Metformin Postpartum for GDM RCT for Reduced Weight Retention

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Diabetes, Gestational

Treatments

Drug: Placebo

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01280409

HSC-MS-10-0426

Details and patient eligibility

About

The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

Full description

At 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. Maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. Women will be counseled regarding diet, exercise and glucose control. Data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. At 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. At 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. Finally, a satisfaction survey will be completed.

Enrollment

114 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postpartum women with a delivery greater than 34 weeks of pregnancy
Between the ages of 18 to 49 years
Women with a diagnosis of gestational diabetes mellitus (either treated with insulin, oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy based on a confirmatory 3 hour glucola test (based on either the Carpenter and Coustan's of the Diabetes Task Force criteria)

Exclusion criteria

women with pre-gestational diabetes mellitus (either Type I or Type II DM)
women unable to tolerate metformin based on patient history
women who will be discharged hom eon insulin or oral hypoglycemic agent in the immediate postpartum period
women with a BMI <25 kg/m²