Metformin and Vascular Function in Prediabetes
NCT06526494 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2025-12-24
Summary
The goal of this clinical trial is to investigate whether metformin improves vascular function in individuals with prediabetes. The main questions it aims to answer are:
1. Does metformin improve large conduit artery endothelial function in individuals with prediabetes?
2. Does metformin improve microvascular endothelial function in individuals with prediabetes?
Researchers will compare metformin to a placebo to see if metformin improves vascular function in prediabetes.
The trial duration is 12 weeks. Participants will take metformin or a placebo once a day for 2 weeks. After 2 weeks, participants will take metformin or a placebo twice a day for the remaining 10 weeks. There will be a screening visit, two baseline visits, a 4-week safety visit, and two 12-week end-of-study visits. Adherence will be calculated from pill count and adverse events will be quantified via a questionnaire.
Conditions
- PreDiabetes
Interventions
- DRUG
-
Metformin
Oral ingestion for 12 weeks
- OTHER
-
Placebo
Oral placebo for 12 weeks
Sponsors & Collaborators
-
Diana Jalal
lead OTHER
Principal Investigators
-
Diana I Jalal, MD · University of Iowa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-13
- Primary Completion
- 2025-12-01
- Completion
- 2025-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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