Overview

Metformin Postpartum for GDM RCT for Reduced Weight Retention

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborator:
Gilstrap, Larry C, M.D.
Treatments:
Metformin
Criteria
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