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Anti-diabetic agent

Metformin for Preventing Type 2 Diabetes After Gestational Diabetes

N/A

Waitlist Available

Led By Gianna Wilkie, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Known diagnosis of pre-existing pre-gestational diabetes in pregnancy

Inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop and test a protocol for screening for diabetes right after childbirth in women who had gestational diabetes during pregnancy. If diabetes is found, the patients will be treated with metformin

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Metformin may cause side effects such as digestive issues like nausea or diarrhea, potential vitamin B12 deficiency over long-term use, and rarely a serious condition called lactic acidosis.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with diabetes before becoming pregnant.

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

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I am currently taking steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detection of Type 2 Diabetes Mellitus

Glycemic Outcomes--Hemoglobin A1c

Secondary study objectives

Patient Recruitment

Patient Retention

Patient Satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met