Lifestyle Change vs Metformin for Recent Gestational Diabetes

Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes

Recruiting Phase 2 Interventional Study
Weight Loss Gestational Diabetes Mellitus in Pregnancy Postpartum Care
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
George Washington University · Other
Who this trial is looking for

This trial is looking for mothers who are 8 weeks to 12 months postpartum after a pregnancy with gestational diabetes. Participants will receive either lifestyle support or Metformin and will track their weight and health over six months.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesType 2 diabetesAdvanced kidney diseaseCongenital heart disease

You may be able to join if

  • I am a mother between 8 weeks and 12 months postpartum.
  • I had a pregnancy complicated by gestational diabetes.
  • I have a BMI between 25 and 45.
  • I had a singleton delivery.
  • I have a working cell phone.
  • I am willing to participate in online sessions.

You may not be able to join if

  • I am pregnant or planning to get pregnant in the next 6 months.
  • I am taking any weight loss medication.
  • I have a normal or underweight BMI.
  • I am carrying twins or triplets.
  • I have type 1 or type 2 diabetes.
  • I have serious health issues like advanced kidney disease.
  • My infant has significant medical conditions like heart disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is: Is a Lifestyle Intervention or Metformin more effective for weight …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by GDM will be recruited. The research team will begin recruiting women who are at least 8 weeks postpartum to provide time to describe the study and answer any questions. Mothers who want to partici…
Contacts

Jennifer R Gomez Berrospi, MPH

202-994-2582

Jengomez291@gwu.edu

CONTACT

Wanda Nicholson, MD

wanda.nicholson@email.gwu.edu

CONTACT