Phase 4
N=114
Metformin Postpartum for GDM RCT for Reduced Weight Retention
Diabetes, Gestational
Bottom Line
View on ClinicalTrials.gov: NCT01280409 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Weight Change — 6.5; 6.3 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metformin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
6.5; 6.3 | — |
| SECONDARY Number of Participants Who Achieved Pre-pregnancy Weight |
16; 15 | — |
| SECONDARY Number of Participants Who Achieved Their Ideal Body Weight |
1; 1 | — |
| SECONDARY Hemoglobin a1c |
— | — |
| SECONDARY HDL, LDL, Triglyceride |
— | — |
| SECONDARY Self-reported Compliance With Medications |
0; 0; 1; 1; 14; 18 | — |
| SECONDARY Self-reported Compliance With Medications |
0; 0; 1; 1; 14; 18 | — |
| SECONDARY Difficulty With Diet as Assessed by a 5-point Likert Scale |
10; 9; 9; 10; 14; 14 | — |
| SECONDARY Difficulty With Exercise as Assessed by a 5-point Likert Scale |
11; 11; 9; 6; 13; 13 | — |
| SECONDARY Difficulty With Medication as Assessed by a 5-point Likert Scale |
15; 14; 7; 6; 5; 7 | — |
| SECONDARY Satisfaction With Diet as Assessed by a 5-point Likert Scale |
2; 6; 5; 7; 9; 8 | — |
| SECONDARY Satisfaction With Exercise as Assessed by a 5-point Likert Scale |
3; 6; 9; 6; 14; 14 | — |
| SECONDARY Satisfaction With Medication as Assessed by a 5-point Likert Scale |
4; 5; 6; 4; 6; 7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01280409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.