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Metformin Postpartum for GDM RCT for Reduced Weight Retention

Primary Purpose

Diabetes, Gestational

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes, Gestational

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Metformin

Arm Description

Compounded placebo

Compounded metformin as the intervention

Outcomes

Primary Outcome Measures

Weight Change
The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2011
Last Updated
November 1, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Gilstrap, Larry C, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01280409
Brief Title
Metformin Postpartum for GDM RCT for Reduced Weight Retention
Official Title
The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Gilstrap, Larry C, M.D.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Compounded placebo
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Compounded metformin as the intervention
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
Primary Outcome Measure Information:
Title
Weight Change
Description
The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)
Time Frame
within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Pre-pregnancy Weight
Time Frame
At 6 weeks postpartum
Title
Number of Participants Who Achieved Their Ideal Body Weight
Time Frame
At 6 weeks postpartum
Title
Hemoglobin a1c
Description
We will calculate the change in hemoglobin a1c.
Time Frame
At 6 weeks postpartum
Title
HDL, LDL, Triglyceride
Description
We will calculate the change in LDL, HDL, and triglyceride levels.
Time Frame
At 6 weeks postpartum
Title
Self-reported Compliance With Medications
Time Frame
3 weeks postpartum
Title
Self-reported Compliance With Medications
Time Frame
6 weeks postpartum
Title
Difficulty With Diet as Assessed by a 5-point Likert Scale
Time Frame
At 6 weeks postpartum
Title
Difficulty With Exercise as Assessed by a 5-point Likert Scale
Time Frame
At 6 weeks postpartum
Title
Difficulty With Medication as Assessed by a 5-point Likert Scale
Time Frame
At 6 weeks postpartum
Title
Satisfaction With Diet as Assessed by a 5-point Likert Scale
Time Frame
At 6 weeks postpartum
Title
Satisfaction With Exercise as Assessed by a 5-point Likert Scale
Time Frame
At 6 weeks postpartum
Title
Satisfaction With Medication as Assessed by a 5-point Likert Scale
Time Frame
At 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrie S Refuerzo, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital, Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston, Professional Building
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Metformin Postpartum for GDM RCT for Reduced Weight Retention

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