Investigating metformin's effects on blood vessel function in prediabetes
Metformin and Vascular Function in Prediabetes
PHASE2 · University of Iowa · NCT06526494
This study is testing if the diabetes medication metformin can help improve blood vessel function in people with prediabetes over 12 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Trial ID | NCT06526494 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether metformin can improve vascular function in individuals diagnosed with prediabetes. The study will compare the effects of metformin against a placebo over a 12-week period, with participants taking the medication or placebo daily. Researchers will assess both large conduit artery and microvascular endothelial function to evaluate the potential vascular benefits of metformin. The trial will involve multiple visits for screening, safety assessments, and end-of-study evaluations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-55 with prediabetes, defined by an HbA1c between 5.7% and 6.4%.
Not a fit: Patients with a history of diabetes, significant cardiovascular issues, or contraindications to metformin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve vascular health and reduce cardiovascular risks in individuals with prediabetes.
How similar studies have performed: While metformin has shown vascular benefits in diabetes, its effects on endothelial function specifically in prediabetes remain largely unexplored, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Iowa City, Iowa and 1 other locations
- University of Iowa — Iowa City, Iowa, United States (RECRUITING)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (RECRUITING)
Study contacts
- Principal investigator: Diana I Jalal, MD — University of Iowa
- Study coordinator: Diana I Jalal, MD
- Email: diana-jalal@uiowa.edu
- Phone: 319 338 0581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PreDiabetes, vascular function, metformin, prediabetes