RECRUITING

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Quick Facts

Study Start:2021-12-13
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05051436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hemoglobin A1C between 5.7 and 6.4
  2. * Body mass index between 27 and 45
  1. * Diabetes
  2. * Chronic use of any antidiabetic medications
  3. * Any unstable medical condition
  4. * Use of steroids or daily use of NSAIDS
  5. * History of chronic inflammatory conditions
  6. * Use of anticoagulants
  7. * Contraindications to the use of mirabegron or tadalafil
  8. * Any condition deemed risky by the study physician

Contacts and Locations

Study Contact

Douglas Long, M.S.
CONTACT
859-323-5438
delong2@uky.edu
Philip Kern, M.D.
CONTACT
859-218-1394
pake222@uky.edu

Principal Investigator

Philip Kern, M.D.
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Philip Kern

  • Philip Kern, M.D., PRINCIPAL_INVESTIGATOR, University of Kentucky

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

Study Start Date2021-12-13
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2021-12-13
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

  • Tadalafil
  • Mirabegron

Additional Relevant MeSH Terms

  • Pre-diabetes
  • Obesity