Metformin Postpartum for GDM RCT for Reduced Weight Retention

• ClinicalTrials.gov Identifier: NCT01280409
• Recruitment Status: Completed
• First Posted: January 20, 2011
• Results First Posted: November 28, 2018
• Last Update Posted: November 28, 2018
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Gilstrap, Larry C, M.D.
• Information provided by (Responsible Party): Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Study Description

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 Design

• 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
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT01280409
• Other Study ID Numbers: HSC-MS-10-0426
• First Posted: January 20, 2011
• Results First Posted: November 28, 2018
• Last Update Posted: November 28, 2018
• Last Verified: November 2018

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