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Status:

WITHDRAWN

Metformin and Vascular Function in Prediabetes

Lead Sponsor:

Diana Jalal

Conditions:

PreDiabetes

Eligibility:

All Genders

18-55 years

Phase:

PHASE2

Brief 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 lar...

Detailed Description

Prediabetes affects approximately 98 million people in the United States and significantly elevates the risk of cardiovascular disease (CVD) and progression to type-2 diabetes. Endothelial dysfunction...

Eligibility Criteria

Inclusion

  • Age 18-55 years
  • Prediabetes defined as an HbA1c between 5.7% and 6.4%
  • Able to provide informed consent

Exclusion

  • Current use of metformin or metformin use within the past 12 months
  • Current use of medicated contraindicated for use with metformin
  • Current use of vitamin C supplement
  • Current smoker or quit smoking within the last 6 months
  • Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate birth control
  • Uncontrolled hypertension (Systolic blood pressure \>140 mmHg)
  • Body Mass Index \> 40 kg/m2
  • History of diabetes, myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate \< 45 ml/min/1.73m2)
  • History of lactic acidosis
  • History of alcohol abuse
  • Severe infection within the last 30 days
  • Immunosuppressive therapy within the past year
  • Life expectancy \< 1 year
  • Allergy to metformin, nitroglycerin, sodium nitroprusside, ringer's lactate
  • Study compliance: Unwilling to fast overnight, have an intravenous catheter placed, take a study drug for 12 weeks, or visit Iowa campus 6 times within a 12-16 week period

Key Trial Info

Start Date :

November 13 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06526494

Start Date

November 13 2024

End Date

December 1 2025

Last Update

December 24 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Iowa

Iowa City, Iowa, United States, 52242

2

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52245