Mechanisms for Activation of Beige Adipose Tissue in Humans

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Philip Kern
Study ID
NCT04666636
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Participants will take one pill (placebo) daily for the first week and two pills daily for the remaining 15 weeks.
  • Mirabegron — DRUG
    Participants will take one pill (50mg Mirabegron) daily for the first week. For week two, participants will take two pills (50mg and 25mg Mirabegron). Unless there are side effects, for the remaining 14 weeks participants will take two pills (50mg each) daily.
  • Mirabegron 50 MG — DRUG
    Participants will take one pill (50mg Mirabegron) daily between visit 2 and visit 3
  • Mirabegron 100 mg — DRUG
    participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks. Next participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks. Last participants will be given 6 weeks of mirabegron (100 mg) and take 1 pill once per day for 4-6 weeks.

Study Details

Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients

Key Dates

Start date
Dec 7, 2020
Status verified
Oct 2025
Primary completion
Jun 25, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
    Participants in the group will receive placebo.
  • Experimental: Mirabegron
    Participants in this group will receive Mirabegron for 16 weeks.
  • Experimental: Sub-Study: Mirabegron and the acute response to food
    This sub-study will involve the recruiting of the same subjects who are eligible for this study as described above. Subjects will report to the CCTS fasting on 3 separate days. On each visit, the subject will have 5 blood draws and each blood draw will be about 8 ml, for a total of 40 ml of blood at each visit. Visit 1 will involve the participant consuming a standardized meal. At visit 2, participants will take 50mg of Mirabegron. And visit 3 will involve the participant consuming the same meal as visit 1 and also taking 50 mg of mirabegron.
  • Experimental: Sub-Study: Mirabegron dosing and Oral Glucose Tolerance Tests (Optional)
    Studies have found that larger doses of mirabegron do not elicit the same improvements in insulin sensitivity. Therefore, we aim to perform a dose-response study to gain an improved understanding of mirabegron dosing and changes in insulin sensitivity. This sub-study will have 4 total visits. visit 1 is a baseline oral glucose tolerance test. At the end of visit 1, participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks leading up to visit 2. Visit 2 will also be a standard oral glucose tolerance test. At the end of visit 2, participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks leading up to visit 3. Visit 3 will also be a standard oral glucose tolerance test. At the end of visit 3, participants will be given 6 weeks of mirabegron (10 mg) and take 1 pill once per day for 4-6 weeks. Visit 4 will be the final visit and will also be a standard oral glucose tolerance test.

Primary Outcome Measure

Change in Glucose Tolerance [ Time Frame: 16 weeks (at baseline and at 16 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Zach Leicht
[email protected]
859-218-1397
Philip Kern, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kentucky· Lexington, KY

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