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Metformin Postpartum for GDM RCT for Reduced Weight Retention

NCT01280409 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-11-28

Study results available
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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.

Conditions

  • Diabetes, Gestational

Interventions

DRUG

Metformin

Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks

DRUG

Placebo

Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.

Sponsors & Collaborators

  • Gilstrap, Larry C, M.D.

    collaborator INDIV

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jerrie S Refuerzo, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-03-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280409 on ClinicalTrials.gov