Clinical trial

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Recruiting now · Phase 4 · 1 countries · Registry ID NCT05051436

Recruiting nowPhase 4Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionPre-diabetes, Obesity

Full registry 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

Treatments and study arms

Mirabegron 50 MG

Drug

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

Tadalafil 10 MG

Drug

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

Placebo

Drug

Placebo will be administered for 14 weeks after baseline procedures.

Primary outcomes

Oral glucose tolerance testBaseline

Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.

Oral glucose tolerance test14 weeks

Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Kentucky🇺🇸 Lexington, Kentucky, United States

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Zach LeichtContact

Email · Call 859-218-1397

Philip Kern, M.D.Principal Investigator