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Metformin Postpartum for GDM RCT for Reduced Weight Retention

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ClinicalTrials.gov Identifier: NCT01280409
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
Gilstrap, Larry C, M.D.
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Drug: Metformin Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial
Study Start Date : January 2011
Primary Completion Date : March 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Weight Change [ Time Frame: At 6 weeks postpartum visit (2nd research visit) ]

    The weight change in kilograms defined as:

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



Secondary Outcome Measures :
  1. Achievement of pre-pregnancy weight [ Time Frame: At 6 weeks postpartum ]
    We will calculate the percentage of women that achieve their self-reported pre-pregnancy weight.

  2. Ideal Body weight [ Time Frame: At 6 weeks postpartum ]
    We will calculate the percentage of women that achieve their ideal body weight.

  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. Satisfaction Survey [ Time Frame: At 6 weeks postpartum ]
    Results of the satisfaction survey will be analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280409


Locations
United States, Texas
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston, Professional Building
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Gilstrap, Larry C, M.D.
Investigators
Principal Investigator: Jerrie S Refuerzo, MD The University of Texas Health Science Center, Houston

Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01280409     History of Changes
Other Study ID Numbers: HSC-MS-10-0426
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs