Metformin Postpartum for GDM

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01280409
First received: January 19, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Diabetes, Gestational
Drug: Metformin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Weight Change [ Time Frame: At 6 weeks postpartum visit (2nd research visit) ] [ Designated as safety issue: No ]

    The weight change in kilograms defined as:

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



Secondary Outcome Measures:
  • Achievement of pre-pregnancy weight [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the percentage of women that achieve their self-reported pre-pregnancy weight.

  • Ideal Body weight [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the percentage of women that achieve their ideal body weight.

  • Hemoglobin a1c [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the change in hemoglobin a1c.

  • HDL, LDL, triglyceride [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the change in LDL, HDL, and triglyceride levels.

  • Satisfaction Survey [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    Results of the satisfaction survey will be analyzed.


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280409

Contacts
Contact: Jerrie S Refuerzo, MD 713.500.6416 Jerrie.S.Refuerzo@uth.tmc.edu
Contact: Maria S Hutchinson, MS 713.500.5850 Maria.S.Keefer@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital, Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Jerrie S Refuerzo, MD    713-500-6416    Jerrie.S.Refuerzo@uth.tmc.edu   
University of Texas Health Science Center at Houston, Professional Building Recruiting
Houston, Texas, United States, 77030
Contact: Jerrie S Refuerzo, MD    713-500-6416    Jerrie.S.Refuerzo@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research
Investigators
Principal Investigator: Jerrie S Refuerzo, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Jerrie Refuerzo, MD, University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT01280409     History of Changes
Other Study ID Numbers: HSC-MS-10-0426
Study First Received: January 19, 2011
Last Updated: May 18, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014