NCT05051436PHASE4RecruitingAccepts Healthy Volunteers

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Philip Kern

Start Date

12/13/2021

Completion Date

8/1/2026

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

Age Range: 35 years to 65 years

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

Interventions

DRUG

Mirabegron 50 MG

DRUG

Tadalafil 10 MG

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pre-diabetesObesity

Locations

University of Kentucky

Lexington, Kentucky 40536

United States