RecruitingPhase 2NCT04666636

Mechanisms for Activation of Beige Adipose Tissue in Humans

Sponsor

Philip Kern

Enrollment

65 participants

Start Date

Dec 7, 2020

Study Type

INTERVENTIONAL

Summary

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

Eligibility

Min Age: 35 YearsMax Age: 65 Years

Inclusion Criteria3

BMI 27-45
prediabetes (A1c 5.7-6.4)
impaired fasting glucose or impaired glucose tolerance

Exclusion Criteria8

diabetes
chronic use of anti-diabetic medication
acute or chronic inflammatory condition
unstable medical condition
cancer
renal insufficiency
any contraindication for Mirabegron
BMI >45

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Interventions

DRUGPlacebo

Participants will take one pill (placebo) daily for the first week and two pills daily for the remaining 15 weeks.

DRUGMirabegron

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.

DRUGMirabegron 50 MG

Participants will take one pill (50mg Mirabegron) daily between visit 2 and visit 3

DRUGMirabegron 100 mg

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.

Locations(1)

University of Kentucky

Lexington, Kentucky, United States

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NCT04666636