NCT01783470

Brief Summary

This study will test the hypothesis that human brown adipose tissue (BAT) can be activated using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared with cold exposure, which we have already shown can activate human BAT, as well as a placebo control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 11, 2017

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

January 29, 2013

Results QC Date

March 9, 2017

Last Update Submit

May 31, 2019

Conditions

Obesity

Keywords

adipose tissue, brownobesityAdrenergic beta-3 Receptor Agoniststhermogenesismetabolism

Outcome Measures

Primary Outcomes (1)

  • BAT Activity as Measured by 18F-FDG PET/CT

    difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue.

    60 min after FDG administration

Other Outcomes (1)

  • Whole-body Energy Expenditure

    30 minutes before drug administration followed by 30 minutes after FDG administration

Study Arms (1)

beta3-adrenergic receptor agonist

EXPERIMENTAL

single dose. Each subject was randomized to receive placebo at one visit and then the beta3-adrenergic receptor agonist on another study day.

Drug: beta3-adrenergic receptor agonist

Interventions

beta3-adrenergic receptor agonistDRUG

single dose. The subjects were randomized to receive placebo on one study day and active beta3-adrenergic receptor agonist on the other study day.

Also known as: mirabegron, which is Myrbetriq (TM) by Astellas Pharma
beta3-adrenergic receptor agonist

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Male
  • years old
  • BMI between 18-40
  • Not participated in clinical trial and received either an investigational or marketed drug within two months prior to the study
  • Not donated blood in previous two months

You may not qualify if:

  • Women
  • History of local or systemic infection disease with fever or requiring antibiotic within 4 weeks of drug administration
  • Corrected QT interval above normal
  • Laboratory test results that is more than 1.5 fold outside normal range and/or is judged to be clinically significant
  • Current addition to alcohol or substances of abuse
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Use of system course of corticosteroids or other medication known to cause insulin resistance in previous 6 weeks
  • Hyperthyroidism,hypothyroidism, hypertension (even if controlled with medications), heart disease (including CAD and CHF), cardiac arrhythmias, diabetes, unstable vasomotor system, or use of monoamine oxidase (MAO) inhibitors
  • Diagnosis of bladder outlet obstruction or use of any medication to treat overactive bladder (e.g. Tolterodine, Solifenacin, Propiverine, Oxybutynin, and Fesoterodine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

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: 25565203RESULT

MeSH Terms

Conditions

Obesity

Interventions

Adrenergic beta-3 Receptor Agonistsmirabegron

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic beta-AgonistsAdrenergic AgonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Results Point of Contact

Title
Aaron M. Cypess, MD, PhD, MMSc
Organization
NIDDK / NIH
aaron.cypess@nih.gov
301-435-9267

Study Officials

  • Aaron M Cypess, MD PhD

    NIDDK, NIH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Investigator, NIDDK, NIH

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 5, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 11, 2019

Results First Posted

May 11, 2017

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)