Overview

Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Aaron Cypess
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Treatments:
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-3 Receptor Agonists
Mirabegron
Criteria
Inclusion Criteria:

- Healthy Male

- 18-65 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

Exclusion Criteria:

- 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)