Metformin and Vascular Function in Prediabetes

NCT06526494 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-12-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526494 on ClinicalTrials.gov