Metformin and Vascular Function in Prediabetes

Description

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

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Study Overview

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Study Details

Study overview

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.

Metformin and Vascular Function in Prediabetes

Metformin and Vascular Function in Prediabetes

Condition
PreDiabetes
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Diana Jalal,

Diana I Jalal, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2026-10-01