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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Primary Purpose

Pre-diabetes, Obesity

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mirabegron 50 MG
Tadalafil 10 MG
Placebo
Sponsored by
Philip Kern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes focused on measuring Tadalafil, Mirabegron

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Mirabegron (M)

Tadalafil (T)

Mirabegron and Tadalafil (MT)

Placebo (P)

Arm Description

Drug will be administered for 12 weeks after baseline procedures.

Drug will be administered for 12 weeks after baseline procedures.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Hemoglobin A1C
Participant hemoglobin A1C will be evaluated at baseline.
Hemoglobin A1C
Participant hemoglobin A1C will be evaluated at 14 weeks.

Full Information

First Posted
September 10, 2021
Last Updated
October 11, 2022
Sponsor
Philip Kern
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05051436
Brief Title
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Official Title
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philip Kern
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Obesity
Keywords
Tadalafil, Mirabegron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirabegron (M)
Arm Type
Experimental
Arm Description
Drug will be administered for 12 weeks after baseline procedures.
Arm Title
Tadalafil (T)
Arm Type
Experimental
Arm Description
Drug will be administered for 12 weeks after baseline procedures.
Arm Title
Mirabegron and Tadalafil (MT)
Arm Type
Experimental
Arm Description
Both drugs will be administered for 12 weeks after baseline procedures.
Arm Title
Placebo (P)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mirabegron 50 MG
Intervention Description
Mirabegron 50 mg/day will be administered for 14 weeks.
Intervention Type
Drug
Intervention Name(s)
Tadalafil 10 MG
Intervention Description
Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered for 14 weeks after baseline procedures.
Primary Outcome Measure Information:
Title
Oral glucose tolerance test
Description
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.
Time Frame
Baseline
Title
Oral glucose tolerance test
Description
Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin A1C
Description
Participant hemoglobin A1C will be evaluated at baseline.
Time Frame
Baseline
Title
Hemoglobin A1C
Description
Participant hemoglobin A1C will be evaluated at 14 weeks.
Time Frame
14 weeks
Other Pre-specified Outcome Measures:
Title
Fat biopsy
Description
Beiging of fat as measured in the lab by histochemistry.
Time Frame
Baseline
Title
Fat biopsy
Description
Beiging of fat as measured in the lab by histochemistry.
Time Frame
14 weeks
Title
Muscle biopsy
Description
Fiber type, as measured in the lab by histochemistry.
Time Frame
Baseline
Title
Muscle biopsy
Description
Fiber type, as measured in the lab by histochemistry.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas Long, M.S.
Phone
859-323-5438
Email
delong2@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Kern, M.D.
Phone
859-218-1394
Email
pake222@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Kern, M.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Long
Phone
859-323-5438
Email
delong2@uky.edu
First Name & Middle Initial & Last Name & Degree
Philip Kern, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

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