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GDM: Insulin with or Without Metformin?

RECRUITINGPhase 4Sponsored by University of Virginia
Actively Recruiting
PhasePhase 4
SponsorUniversity of Virginia
Started2024-12-12
Est. completion2026-05-01
Eligibility
Age18 Years – 50 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.

Eligibility

Age: 18 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
4. Ability to take oral medication and be willing to adhere to the metformin regimen
5. Willing to take insulin if needed
6. Willing to take blood sugars 4 times per day

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   Exclusion Criteria:
   * 1\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy

Conditions2

DiabetesGestational Diabetes

Locations1 site

University of Virginia
Charlottesville, Virginia, 22903
Amanda Urban4344093100ajr5y@uvahealth.org

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