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

NCT02354807 | Unknown Phase 2 DMC

• 1 other identifier: WSU_OVPR1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brown Fat

Keywords

BAT activation; quantitative PET imaging; Mirabegron effect on BAT

Outcome Measures

Primary Outcomes (1)

• SUV as a measure of glucose metabolism

  SUV value in supraclavicular BAT and subcutaneous WAT

  4 hours

Secondary Outcomes (1)

• Blood Flow

  4 hours

Study Arms (1)

Experimental group

EXPERIMENTAL

Subjects that undergo both cold exposure and one-time dose of 100mg of Mirabegron drug

Drug: Mirabegron; Other: Cold exposure

Interventions

Mirabegron DRUG

One-time dose of 100mg of Mirabegron

Also known as: Myrbetriq

Experimental group

Cold exposure OTHER

Exposure of subjects to cold temperature to induce non-shivering thermogenesis

Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto Muzik: lead

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Related Publications (1)

• Cypess AM, Weiner LS, Roberts-Toler C, Franquet Elia E, Kessler SH, Kahn PA, English J, Chatman K, Trauger SA, Doria A, Kolodny GM. Activation of human brown adipose tissue by a beta3-adrenergic receptor agonist. Cell Metab. 2015 Jan 6;21(1):33-8. doi: 10.1016/j.cmet.2014.12.009.

  PMID: 25565203 RESULT

MeSH Terms

Interventions

mirabegron

Study Officials

• Otto Muzik

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otto Muzik, PhD

CONTACT

313-993-2616; otto@pet.wayne.edu

James Granneman, PhD

CONTACT

313-577-5629; jgranne@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics & Radiology

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 3, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

US (1)