Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
1 other identifier
interventional
25
1 country
1
Brief Summary
In this study the investigators aim to quantitate the extent of cervical and upper thoracic brown adipose tissue (BAT) activation in lean and obese humans via positron emission tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological adrenergic stimulus will result in activation of BAT in these participants, and that this activation will be reduced in obese patients. This study will provide important preliminary information with respect to allowing the investigators to progress with longer trials with specific beta 3 AR agonists.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFebruary 15, 2013
November 1, 2009
3 years
October 29, 2009
February 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
BAT activity via PET-CT
Baseline and 3 weeks
Study Arms (1)
Adrenergic agonist
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Males aged 20 - 40 years
- Free of overt coronary disease (on history, medical examination and ECG)
- Fasting plasma glucose \< 6.1 mmol/L and 2 hour OGTT glucose \< 7.8 mmol/L
- Unmedicated
- No major illness
- BMI 18 - 25
- Males aged 20 - 40 years
- Free of overt coronary disease (on history, medical examination and ECG)
- Unmedicated
- No major illness
- BMI 30+
- Weight \< 100 kg
- Height \< 185 cm
You may not qualify if:
- Unable to give informed consent
- Smokers
- Lactose intolerance
- Unable to give informed consent
- Smokers
- Lactose intolerance
- Participant in research projects involving ionising radiation within the past 5 years
- claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
Study Sites (1)
Alfred Hospital Heart Centre
Prahran, Victoria, 3004, Australia
Related Publications (1)
Carey AL, Formosa MF, Van Every B, Bertovic D, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Ephedrine activates brown adipose tissue in lean but not obese humans. Diabetologia. 2013 Jan;56(1):147-55. doi: 10.1007/s00125-012-2748-1. Epub 2012 Oct 13.
PMID: 23064293RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
November 18, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2012
Last Updated
February 15, 2013
Record last verified: 2009-11