Metformin Postpartum for GDM RCT for Reduced Weight Retention

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01280409

Enrollment

114

Registered

2011-01-20

Start date

2011-01-31

Completion date

2014-08-31

Last updated

2018-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational

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.

Interventions

DRUGMetformin

Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Weight Change	within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)	The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo Compounded placebo Placebo: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.	43
Metformin Compounded metformin as the intervention Metformin: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks	36
Total	79

Baseline characteristics

Characteristic	Metformin	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	36 Participants	43 Participants	79 Participants
Age, Continuous	31.6 years STANDARD_DEVIATION 5.3	28.8 years STANDARD_DEVIATION 6.4	30.2 years STANDARD_DEVIATION 5.8
Region of Enrollment United States	36 Participants	43 Participants	79 Participants
Sex: Female, Male Female	36 Participants	43 Participants	79 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	7 / 56	12 / 46
serious Total, serious adverse events	0 / 56	0 / 46

Outcome results

Primary

Weight Change

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)

Arm	Measure	Value (MEDIAN)
Placebo	Weight Change	6.5 kg
Metformin	Weight Change	6.3 kg

Secondary