RecruitingPhase 2

Mechanisms for Activation of Beige Adipose Tissue in Humans

United States65 participantsStarted 2020-12-07

Plain-language 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

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI 27-45 * prediabetes (A1c 5.7-6.4) * impaired fasting glucose or impaired glucose tolerance Exclusion Criteria: * diabetes * chronic use of anti-diabetic medication * acute or chronic inflammatory condition * unstable medical condition * cancer * renal insufficiency * any contraindication for Mirabegron * BMI \>45

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Glucose Tolerance

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Body Composition

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Resting Metabolic Rate

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Brown Adipose Tissue Activity

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Peripheral Insulin Sensitivity

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Insulin Secretion

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in glycohemoglobin

Timeframe: 16 weeks (at baseline and at 16 weeks)

Trial details

NCT IDNCT04666636

SponsorPhilip Kern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Zach Leicht

859-218-1397 zachary.leicht@uky.edu

View on ClinicalTrials.gov More PreDiabetes trials

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Glucose Tolerance

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Body Composition

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Resting Metabolic Rate

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Brown Adipose Tissue Activity

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Peripheral Insulin Sensitivity

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in Insulin Secretion

Timeframe: 16 weeks (at baseline and at 16 weeks)

Change in glycohemoglobin

Timeframe: 16 weeks (at baseline and at 16 weeks)