The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
NCT ID: NCT05051436
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
96 participants
INTERVENTIONAL
2021-12-13
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mirabegron (M)
Drug will be administered for 12 weeks after baseline procedures.
Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks.
Tadalafil (T)
Drug will be administered for 12 weeks after baseline procedures.
Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Mirabegron and Tadalafil (MT)
Both drugs will be administered for 12 weeks after baseline procedures.
Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks.
Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Placebo (P)
Placebo
Placebo will be administered for 14 weeks after baseline procedures.
Interventions
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Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks.
Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Placebo
Placebo will be administered for 14 weeks after baseline procedures.
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 27 and 45
Exclusion Criteria
* 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
35 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Philip Kern
OTHER
Responsible Party
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Philip Kern
Professor
Principal Investigators
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Philip Kern, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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55665
Identifier Type: -
Identifier Source: org_study_id
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