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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
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.
Conditions:
🦠 Pre-diabetes 🦠 Obesity
🗓️ Study Start (Actual) 13 December 2021
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 28 February 2025
👥 Enrollment (Estimated) 96
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Lexington, Kentucky, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 35 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 September 2021
  • First Submitted that Met QC Criteria 10 September 2021
  • First Posted 21 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 October 2023
  • Last Update Posted 30 October 2023
  • Last Verified October 2023
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