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NCT05051436
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Conditions: Pre-diabetes, Obesity
Sex: All
Ages: 35 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 96
Sponsor: Philip Kern
Location: University of Kentucky Lexington Kentucky
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
Source: ClinicalTrials.gov (NCT05051436). StuddyBuddy aggregates publicly available trial information.