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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01015794
Registration number
NCT01015794
Ethics application status
Date submitted
29/10/2009
Date registered
18/11/2009
Date last updated
15/02/2013
Titles & IDs
Public title
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
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Scientific title
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
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Secondary ID [1]
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404/09
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ephedrine hydrochloride
Treatment: Drugs - ephedrine hydrochloride
Experimental: Adrenergic agonist -
Treatment: Drugs: ephedrine hydrochloride
single oral dose, 1mg/kg body weight
Treatment: Drugs: ephedrine hydrochloride
single dose of 1 mg/kg body weight
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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BAT activity via PET-CT
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Assessment method [1]
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Timepoint [1]
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Baseline and 3 weeks
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Eligibility
Key inclusion criteria
healthy group
- 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
obese group
- 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
The inclusion criteria (Obese participants) of body weight less than ~100 kg is implemented
as the PET-CT scanner to be utilised (protocol described subsequently) has a limited
patient volume. Therefore to fit within the criteria of BMI > 30, only patients of height
~183 cm or less can be recruited, and inclusion of borderline participants will be
discussed with co-investigators from the Alfred Hospital Nuclear Medicine Department.
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Minimum age
20
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
healthy group
- Unable to give informed consent
- Smokers
- Lactose intolerance
obese group
- Unable to give informed consent
- Smokers
- Lactose intolerance
- Participant in research projects involving ionising radiation within the past 5 years
- claustrophobia
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital Heart Centre - Prahran
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Recruitment postcode(s) [1]
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3004 - Prahran
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01015794
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01015794
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