Recruiting PHASE2 Weight Loss

Compares treatment options for Weight Loss

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

ClinicalTrials.gov ID: NCT06948825

What this study is testing

What is Metformin Hcl 850Mg Tab?

Metformin Hcl 850Mg Tab is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for weight loss.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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 loss in postpartum women with recent gestational diabetes?
  • Phase 2: a mid-size study of how well it works
  • Time commitment: about 12 weeks
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 45, women only. Healthy volunteers may be eligible.

You may be able to join if

  • Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by GDM will be recruited. The research team will begin recruiting women...
  • BMI of 25 kg/m2 to 45 kg/m2
  • Singleton delivery
  • Participants must also have a working cell phone, be willing to accept email or text messages attend Zoom calls, and be willing to be potentially...

You likely can't join if

  • Pregnant or planned pregnancy within the next 6 months.
  • Participation in any other weight loss program or taking weight loss medication.
  • Normal or underweight BMI (BMI \< 24.9 kg/m2)
  • Multi-fetal (twins or triplets) gestation
  • Women with type 1 or type 2 diabetes, malignancy, other serious co-morbidities (advanced kidney disease, NYHA class 3-4 CHF, advanced COPD)...
  • Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.

The study team makes the final eligibility decision.

Where it's taking place

  • Washington D.C., District of Columbia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.