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Completed

NCT Number: NCT01280409

Metformin Postpartum for GDM RCT for Reduced Weight Retention

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.

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Key information

Conditions

Diabetes, Gestational Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Memorial Hermann Hospital, Texas Medical Center, Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Weight Change

    Time frame: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)

    The weight change in kilograms defined as:

    weight change = Weight(pp) - Weight(6wk)

Secondary outcomes

  1. Number of Participants Who Achieved Pre-pregnancy Weight

    Time frame: At 6 weeks postpartum

  2. Number of Participants Who Achieved Their Ideal Body Weight

    Time frame: At 6 weeks postpartum

  3. Hemoglobin a1c

    Time frame: At 6 weeks postpartum

    We will calculate the change in hemoglobin a1c.

  4. HDL, LDL, Triglyceride

    Time frame: At 6 weeks postpartum

    We will calculate the change in LDL, HDL, and triglyceride levels.

  5. Self-reported Compliance With Medications

    Time frame: 3 weeks postpartum

  6. Self-reported Compliance With Medications

    Time frame: 6 weeks postpartum

  7. Difficulty With Diet as Assessed by a 5-point Likert Scale

    Time frame: At 6 weeks postpartum

  8. Difficulty With Exercise as Assessed by a 5-point Likert Scale

    Time frame: At 6 weeks postpartum

  9. Difficulty With Medication as Assessed by a 5-point Likert Scale

    Time frame: At 6 weeks postpartum

  10. Satisfaction With Diet as Assessed by a 5-point Likert Scale

    Time frame: At 6 weeks postpartum

  11. Satisfaction With Exercise as Assessed by a 5-point Likert Scale

    Time frame: At 6 weeks postpartum

  12. Satisfaction With Medication as Assessed by a 5-point Likert Scale

    Time frame: At 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Gilstrap, Larry C, M.D.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2011
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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