Metformin Postpartum for GDM RCT for Reduced Weight Retention

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)

NCT01234649

Gestational Diabetes Mellitus Type 2 Diabetes Mellitus Metabolic Syndrome +2 more

COMPLETED PHASE3

Treatment to Regress to Normoglycemia in Women with a Recent History of GDM

NCT04873050

Pre Diabetes Postpartum Disorder

RECRUITING PHASE4

Study of Postprandial Incretin Response in Women With Gestational Diabetes

NCT01274052

Gestational Diabetes Mellitus

COMPLETED

Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults

NCT01419535

Endocrine Disease Diabetes

COMPLETED PHASE1/PHASE2

Effect of Metformin on Lactate Metabolism

NCT00390273

Hyperlactatemia

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes, Gestational

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Compounded placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Metformin

Compounded metformin as the intervention

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No