WithdrawnPhase 2

Metformin and Vascular Function in Prediabetes

Stopped: No funding

United States0Started 2024-11-13

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Macrovascular endothelial function

Timeframe: 12 weeks

Trial details

NCT IDNCT06526494

SponsorDiana Jalal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01