Clinical trial NCT01280409: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes, Gestational
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Gilstrap, Larry C, M.D.
First posted: 2011-01-20
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight Change
timeFrame: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
Secondary outcomes:
measure: Number of Participants Who Achieved Pre-pregnancy Weight
timeFrame: At 6 weeks postpartum
measure: Number of Participants Who Achieved Their Ideal Body Weight
timeFrame: At 6 weeks postpartum
measure: Hemoglobin a1c
timeFrame: At 6 weeks postpartum
measure: HDL, LDL, Triglyceride
timeFrame: At 6 weeks postpartum
measure: Self-reported Compliance With Medications
timeFrame: 3 weeks postpartum
measure: Self-reported Compliance With Medications
timeFrame: 6 weeks postpartum
measure: Difficulty With Diet as Assessed by a 5-point Likert Scale
timeFrame: At 6 weeks postpartum
measure: Difficulty With Exercise as Assessed by a 5-point Likert Scale
timeFrame: At 6 weeks postpartum
measure: Difficulty With Medication as Assessed by a 5-point Likert Scale
timeFrame: At 6 weeks postpartum
measure: Satisfaction With Diet as Assessed by a 5-point Likert Scale
timeFrame: At 6 weeks postpartum
measure: Satisfaction With Exercise as Assessed by a 5-point Likert Scale
timeFrame: At 6 weeks postpartum
measure: Satisfaction With Medication as Assessed by a 5-point Likert Scale
timeFrame: At 6 weeks postpartum
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital, Texas Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston, Professional Building
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jerrie S Refuerzo, MD
role: PRINCIPAL_INVESTIGATOR
References: