Metformin Postpartum for GDM RCT for Reduced Weight Retention

Diabetes, Gestational Clinical Trial

Official title:

The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280409
• Other study ID #: HSC-MS-10-0426
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: August 2014

Study information

• Verified date: November 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational

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
• Placebo
Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital, Texas Medical Center	Houston	Texas
United States	University of Texas Health Science Center at Houston, Professional Building	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Gilstrap, Larry C, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)	within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
Secondary	Number of Participants Who Achieved Pre-pregnancy Weight		At 6 weeks postpartum
Secondary	Number of Participants Who Achieved Their Ideal Body Weight		At 6 weeks postpartum
Secondary	Hemoglobin a1c	We will calculate the change in hemoglobin a1c.	At 6 weeks postpartum
Secondary	HDL, LDL, Triglyceride	We will calculate the change in LDL, HDL, and triglyceride levels.	At 6 weeks postpartum
Secondary	Self-reported Compliance With Medications		3 weeks postpartum
Secondary	Self-reported Compliance With Medications		6 weeks postpartum
Secondary	Difficulty With Diet as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Secondary	Difficulty With Exercise as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Secondary	Difficulty With Medication as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Secondary	Satisfaction With Diet as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Secondary	Satisfaction With Exercise as Assessed by a 5-point Likert Scale		At 6 weeks postpartum
Secondary	Satisfaction With Medication as Assessed by a 5-point Likert Scale		At 6 weeks postpartum