The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirabegron 50 MG, Tadalafil 10 MG, Placebo.
- Who it may be relevant to
- Registry conditions: Pre-diabetes, Obesity. Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks. - Drug Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures. - Drug Placebo
Placebo will be administered for 14 weeks after baseline procedures.
Primary outcome measures
- Oral glucose tolerance test [Time frame: Baseline]
- Oral glucose tolerance test [Time frame: 14 weeks]
Secondary outcome measures (2)
- Hemoglobin A1C [Time frame: Baseline]
- Hemoglobin A1C [Time frame: 14 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT05051436 · 55665 · R01DK128033