Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
This study is testing if the medications mirabegron and tadalafil can help people with prediabetes improve their blood sugar levels over 14 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05051436 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of mirabegron, a ß3 agonist, on glucose metabolism in obese, insulin-resistant individuals with prediabetes. Participants will receive either mirabegron, tadalafil, a combination of both, or a placebo over a 14-week period. The goal is to determine if these treatments can improve glucose homeostasis and potentially reverse prediabetes. The study will comprehensively analyze changes in glucose tolerance among the different treatment groups.
Who should consider this trial
Good fit: Ideal candidates are obese individuals with a hemoglobin A1C between 5.7 and 6.4 who are prediabetic.
Not a fit: Patients with diabetes or those on chronic antidiabetic medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to reversing prediabetes and improving metabolic health in obese individuals.
How similar studies have performed: While the combination of mirabegron and tadalafil is a novel approach, previous studies have shown promise in using mirabegron for metabolic improvements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hemoglobin A1C between 5.7 and 6.4 * Body mass index between 27 and 45 Exclusion Criteria: * Diabetes * Chronic use of any antidiabetic medications * Any unstable medical condition * Use of steroids or daily use of NSAIDS * History of chronic inflammatory conditions * Use of anticoagulants * Contraindications to the use of mirabegron or tadalafil * Any condition deemed risky by the study physician
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Philip Kern, M.D. — University of Kentucky
- Study coordinator: Zach Leicht
- Email: zachary.leicht@uky.edu
- Phone: 859-218-1397
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.