NCT05051436 The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
| NCT ID | NCT05051436 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Philip Kern |
| Condition | Pre-diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2021-12-13 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 96 participants in total. It began in 2021-12-13 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.
Eligibility 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
Contact & Investigator
Philip Kern, M.D.
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05051436 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 65 Years, studying Pre-diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05051436 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05051436 currently recruiting?
Yes, NCT05051436 is actively recruiting participants. Contact the research team at zachary.leicht@uky.edu for enrollment information.
Where is the NCT05051436 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT05051436 clinical trial?
NCT05051436 is sponsored by Philip Kern. The principal investigator is Philip Kern, M.D. at University of Kentucky. The trial plans to enroll 96 participants.
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