RecruitingPhase 4NCT05051436

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics


Sponsor

Philip Kern

Enrollment

96 participants

Start Date

Dec 13, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 YearsMax Age: 65 Years

Inclusion Criteria2

  • Hemoglobin A1C between 5.7 and 6.4
  • Body mass index between 27 and 45

Exclusion Criteria8

  • 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

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Interventions

DRUGMirabegron 50 MG

Mirabegron 50 mg/day will be administered for 14 weeks.

DRUGTadalafil 10 MG

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

DRUGPlacebo

Placebo will be administered for 14 weeks after baseline procedures.


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

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NCT05051436


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