Metformin for Preventing Type 2 Diabetes After Gestational Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byGianna Wilkie, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Massachusetts, Worcester

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Eligibility Criteria

This trial is for postpartum patients who had gestational diabetes (GDM) and show signs of high blood sugar. They must have been diagnosed with GDM in their third trimester, be able to give consent, speak English or Spanish, and be capable of undergoing glucose testing immediately after delivery at UMASS Memorial.

Inclusion Criteria

Have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL

Pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria

Able and willing to provide informed consent

+3 more

Exclusion Criteria

I was diagnosed with diabetes before becoming pregnant.

I cannot undergo an oral glucose tolerance test due to past surgeries or conditions.

I am currently taking steroids.

Participant Groups

The study aims to test a protocol where new mothers who had GDM are screened right after giving birth and then treated with Metformin Hydrochloride if they have high blood sugar levels.

2Treatment groups

Experimental Treatment

Active Control

Group I: Early Postpartum GDM ScreeningExperimental Treatment1 Intervention

Subjects who are randomly assigned to this condition will be screened for GDM with the recommended 2-hour glucose tolerance test during their postpartum hospitalization.

Group II: Standard of Care Postpartum ScreeningActive Control1 Intervention

Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of screening with a 2 hour glucose tolerance test at 6-12 weeks postpartum.

Metformin Hydrochloride is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Metformin Hydrochloride for: