Metformin Postpartum for GDM RCT for Reduced Weight Retention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Gestational

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Compounded placebo | Drug: Placebo<br>* Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.<br>|
| Experimental: Metformin<br>Compounded metformin as the intervention | Drug: Metformin<br>* Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Pre-pregnancy Weight |  | At 6 weeks postpartum | 
| Number of Participants Who Achieved Their Ideal Body Weight |  | At 6 weeks postpartum | 
| Hemoglobin a1c | We will calculate the change in hemoglobin a1c. | At 6 weeks postpartum | 
| HDL, LDL, Triglyceride | We will calculate the change in LDL, HDL, and triglyceride levels. | At 6 weeks postpartum | 
| Self-reported Compliance With Medications |  | 3 weeks postpartum | 
| Self-reported Compliance With Medications |  | 6 weeks postpartum | 
| Difficulty With Diet as Assessed by a 5-point Likert Scale |  | At 6 weeks postpartum | 
| Difficulty With Exercise as Assessed by a 5-point Likert Scale |  | At 6 weeks postpartum | 
| Difficulty With Medication as Assessed by a 5-point Likert Scale |  | At 6 weeks postpartum | 
| Satisfaction With Diet as Assessed by a 5-point Likert Scale |  | At 6 weeks postpartum | 
| Satisfaction With Exercise as Assessed by a 5-point Likert Scale |  | At 6 weeks postpartum | 
| Satisfaction With Medication as Assessed by a 5-point Likert Scale |  | At 6 weeks postpartum |