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 range

18 Years – 55 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Macrovascular endothelial function

Timeframe: 12 weeks

Trial details

NCT IDNCT06526494

SponsorDiana Jalal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More PreDiabetes trials