The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Obesity Clinical Trial

Official title:

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051436
• Other study ID #: 55665
• Secondary ID: R01DK128033
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: Douglas Long, M.S.
• Phone: 859-323-5438
• Email: delong2[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pre-diabetes
• Prediabetic State

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Philip Kern	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fat biopsy	Beiging of fat as measured in the lab by histochemistry.	Baseline
Other	Fat biopsy	Beiging of fat as measured in the lab by histochemistry.	14 weeks
Other	Muscle biopsy	Fiber type, as measured in the lab by histochemistry.	Baseline
Other	Muscle biopsy	Fiber type, as measured in the lab by histochemistry.	14 weeks
Primary	Oral glucose tolerance test	Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.	Baseline
Primary	Oral glucose tolerance test	Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.	14 weeks
Secondary	Hemoglobin A1C	Participant hemoglobin A1C will be evaluated at baseline.	Baseline
Secondary	Hemoglobin A1C	Participant hemoglobin A1C will be evaluated at 14 weeks.	14 weeks