Metformin Postpartum for GDM RCT for Reduced Weight Retention

The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes, Gestational
• Intervention / Treatment: Drug: Placebo; Drug: Metformin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital, Texas Medical Center
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston, Professional Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Compounded placebo	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.
Experimental: Metformin; Compounded metformin as the intervention	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)	within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Pre-pregnancy Weight		At 6 weeks postpartum
Number of Participants Who Achieved Their Ideal Body Weight		At 6 weeks postpartum
Hemoglobin a1c	We will calculate the change in hemoglobin a1c.	At 6 weeks postpartum
HDL, LDL, Triglyceride	We will calculate the change in LDL, HDL, and triglyceride levels.	At 6 weeks postpartum
Self-reported Compliance With Medications		3 weeks postpartum
Self-reported Compliance With Medications		6 weeks postpartum
Difficulty With Diet as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Difficulty With Exercise as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Difficulty With Medication as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Satisfaction With Diet as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Satisfaction With Exercise as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Satisfaction With Medication as Assessed by a 5-point Likert Scale		At 6 weeks postpartum

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Gilstrap, Larry C, M.D.
• Investigators: Principal Investigator: Jerrie S Refuerzo, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: HSC-MS-10-0426