Health TrialsbyHealthPanel

Mechanisms for Activation of Beige Adipose Tissue in Humans

ConditionPreDiabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age35-65
SponsorPhilip Kern

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

BMI 27-45

prediabetes (A1c 5.7-6.4)

impaired fasting glucose or impaired glucose tolerance

Disqualifiers

diabetes

chronic use of anti-diabetic medication

acute or chronic inflammatory condition

unstable medical condition

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

65 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: MirabegronExperimental treatment 1 intervention
Group C: Sub-Study: Mirabegron and the acute response to foodExperimental treatment 1 intervention
Group D: Sub-Study: Mirabegron dosing and Oral Glucose Tolerance Tests (Optional)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Glucose Tolerance

The standard oral glucose tolerance test (OGTT) using 75g glucose will be used to assess tolerance.

Time frame
16 weeks (at baseline and at 16 weeks)
2

Change in Body Composition

Body composition (percent body fat) will be measured using dual-energy X-ray absorptiometry (DEXA).

Time frame
16 weeks (at baseline and at 16 weeks)
3

Change in Resting Metabolic Rate

Resting Metabolic Rate (RMR) will be measured using indirect calorimetry.

Time frame
16 weeks (at baseline and at 16 weeks)
4

Change in Brown Adipose Tissue Activity

Brown adipose tissue (BAT) activity will be measured using water-vest cold stimulation combined with positron emission tomography (PET-CT).

Time frame
16 weeks (at baseline and at 16 weeks)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philip Kern

Lead sponsor

University of Kentucky

Sponsor institution

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now