Efficacy of Pharmacological Stimulation of BAT and WAT in Lean and Obese Young Adults

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue (BAT or "Brown Fat") and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3 agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure to cold, the investigators will assess the efficacy of an FDA approved beta3 agonist Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) for increasing oxidative metabolism in supraclavicular BAT and subcutaneous WAT in lean and obese young adults.

The investigators anticipate that both methods to stimulate supraclavicular BAT and subcutaneous WAT will result in similar 18F-labeled fluoro-deoxyglucose (FDG) tracer uptake on positron emission tomography (PET) images as well as oxidative metabolism. This would demonstrate that pharmacological stimulation of BAT is effective and could lead to further, more detailed clinical trials in obese subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Otto Muzik
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• BMI < 25 kg/m2 or BMI > 30 kg/m2

• Able to give study-specific informed consent

• Able to tolerate PET/CT imaging required by protocol, to be performed without sedation and

• Patients who are not on sedative, antidepressant, sedative antihistaminic or narcotic medications.

Exclusion Criteria:

• Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding

• Subjects with cardiac disease or hypertension

• Subjects with history of diabetes

• Subjects with severe renal impairment or subjects with moderate hepatic impairment

• Subjects with severe uncontrolled hypertension.