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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Sponsor
Philip Kern (Other)
Overall Status
Recruiting
CT.gov ID
NCT05051436
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
96
Enrollment
1
Location
4
Arms
23.6
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mirabegron 50 MG
  • Drug: Tadalafil 10 MG
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Actual Study Start Date :
Dec 13, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirabegron (M)

Drug will be administered for 12 weeks after baseline procedures.

Drug: Mirabegron 50 MG
Mirabegron 50 mg/day will be administered for 14 weeks.
Experimental: Tadalafil (T)

Drug will be administered for 12 weeks after baseline procedures.

Drug: Tadalafil 10 MG
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Experimental: Mirabegron and Tadalafil (MT)

Both drugs will be administered for 12 weeks after baseline procedures.

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.
Placebo Comparator: Placebo (P)

Drug: Placebo
Placebo will be administered for 14 weeks after baseline procedures.

Outcome Measures

Primary Outcome Measures

  1. Oral glucose tolerance test [Baseline]

    Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.

  2. Oral glucose tolerance test [14 weeks]

    Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.

Secondary Outcome Measures

  1. Hemoglobin A1C [Baseline]

    Participant hemoglobin A1C will be evaluated at baseline.

  2. Hemoglobin A1C [14 weeks]

    Participant hemoglobin A1C will be evaluated at 14 weeks.

Other Outcome Measures

  1. Fat biopsy [Baseline]

    Beiging of fat as measured in the lab by histochemistry.

  2. Fat biopsy [14 weeks]

    Beiging of fat as measured in the lab by histochemistry.

  3. Muscle biopsy [Baseline]

    Fiber type, as measured in the lab by histochemistry.

  4. Muscle biopsy [14 weeks]

    Fiber type, as measured in the lab by histochemistry.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky Lexington Kentucky United States 40536

Sponsors and Collaborators

  • Philip Kern
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Philip Kern, M.D., University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philip Kern, Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT05051436
Other Study ID Numbers:
  • 55665
  • R01DK128033
First Posted:
Sep 21, 2021
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Philip Kern, Professor, University of Kentucky
Tadalafil
Mirabegron
Additional relevant MeSH terms:
Prediabetic State
Tadalafil
Mirabegron

Study Results

No Results Posted as of Jan 4, 2022