The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Recruiting · NCT05051436 · Interventional (participants receive a specific treatment) · Lead sponsor: Philip Kern
View the official record on ClinicalTrials.gov →Interventions studied
Mirabegron 50 MGPlaceboTadalafil 10 MG
What this trial is about
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.
Who can take part
Age range
35 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Kentucky - Lexington, Kentucky, United States