Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/8/2018 |
| Start Date: | February 2013 |
| End Date: | December 2019 |
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.
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.
This study will include an outpatient screening visit and three separate, independent
overnight study visits in the General Clinical Research Center (GCRC) at Beth Israel
Deaconess Medical Center (BIDMC). Screening procedures will consist of a medical history,
physical examination, blood draw, and ECG. If, from the screening tests, it is determined
that the eligibility criteria have been meet, healthy volunteers will participate in three
separate inpatient visits at BIDMC. Study procedures will occur in the GCRC and the Nuclear
Medicine suite at BIDMC.
Volunteers will first complete Day A, in which we will measure BAT volume and activity during
cold exposure. Cold exposure will consist of wearing a cooling vest at 55 - 61°F, a
temperature shown to be cool enough to activate brown adipose tissue but warm enough not to
lead to shivering. Resting metabolic rate (RMR) will be measured by indirect calorimetry
before and during cool exposure.
If there is detectable brown fat activity on Day A, volunteers will participate in Days B and
C. Days B and C will be conducted in random order to reduce any bias from the sequence of
treatment and scans, as well as any potential placebo effects. Day B will consist of
pharmacological stimulation with β3-AR agonist. On Day C, volunteers will be given a placebo
control and will not undergo cooling.
A blood draw of 26 cc will always be done prior to FDG injection and FDG PET/CT will always
be performed 60 minutes after FDG injection. On Day A, FDG will be injected after 60 minutes
of cool exposure and the volunteer will remain in the cooling vest for another 60 minutes
after FDG injection.
To compare energy expenditure and BAT mass and activity among volunteers, we will normalize
the data to fat and muscle mass. Whole-body and regional fat and muscle mass will be measured
via a Dual Energy X-ray Absorptiometry (DXA) scan at the end of Day A.
overnight study visits in the General Clinical Research Center (GCRC) at Beth Israel
Deaconess Medical Center (BIDMC). Screening procedures will consist of a medical history,
physical examination, blood draw, and ECG. If, from the screening tests, it is determined
that the eligibility criteria have been meet, healthy volunteers will participate in three
separate inpatient visits at BIDMC. Study procedures will occur in the GCRC and the Nuclear
Medicine suite at BIDMC.
Volunteers will first complete Day A, in which we will measure BAT volume and activity during
cold exposure. Cold exposure will consist of wearing a cooling vest at 55 - 61°F, a
temperature shown to be cool enough to activate brown adipose tissue but warm enough not to
lead to shivering. Resting metabolic rate (RMR) will be measured by indirect calorimetry
before and during cool exposure.
If there is detectable brown fat activity on Day A, volunteers will participate in Days B and
C. Days B and C will be conducted in random order to reduce any bias from the sequence of
treatment and scans, as well as any potential placebo effects. Day B will consist of
pharmacological stimulation with β3-AR agonist. On Day C, volunteers will be given a placebo
control and will not undergo cooling.
A blood draw of 26 cc will always be done prior to FDG injection and FDG PET/CT will always
be performed 60 minutes after FDG injection. On Day A, FDG will be injected after 60 minutes
of cool exposure and the volunteer will remain in the cooling vest for another 60 minutes
after FDG injection.
To compare energy expenditure and BAT mass and activity among volunteers, we will normalize
the data to fat and muscle mass. Whole-body and regional fat and muscle mass will be measured
via a Dual Energy X-ray Absorptiometry (DXA) scan at the end of Day A.
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)
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