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Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment

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ClinicalTrials.gov Identifier: NCT02236962
Recruitment Status : Unknown
Verified September 2014 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Collaborators:
Baker Heart and Diabetes Institute
The Alfred
Information provided by (Responsible Party):
Bayside Health

Brief Summary:
Obesity is epidemic in Australia, and current preventative strategies have had limited success in alleviating this health crisis. While numerous options are available for treatment of obesity, most do not result in sustained weight reduction. Obesity results from an imbalance between energy intake and expenditure, therefore new methods that correct this imbalance are essential for effective long-term treatment. Rodent studies show that brown adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore targeting BAT to increase its activity (energy burning rate) and quantity in humans is potentially a powerful tool for the treatment of obesity and related diseases. BAT has only recently been irrefutably identified in adult humans therefore little is known about how it functions in humans.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Cardiovascular Disease Drug: Placebo Drug: Ephedrine, pioglitazone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment
Study Start Date : April 2012
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ephedrine

Arm Intervention/treatment
Placebo Comparator: Placebo
lactose powder in equivalent capsule
Drug: Placebo
Experimental: Drug treatment
sympathetic agonist and thiazolidinedione
Drug: Ephedrine, pioglitazone



Primary Outcome Measures :
  1. brown adipose tissue activity [ Time Frame: 3 years ]
    measured via PET-CT



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males aged 19 - 35 years
  • Free of overt coronary disease (on history, medical examination and ECG)
  • Unmedicated
  • No major illness
  • BMI <27 kg/m2

Exclusion Criteria:

  • Unable to give informed consent
  • Smokers
  • Participant in research projects involving ionising radiation within the past 5 years.
  • Claustrophobia
  • Fasting plasma glucose > 6.0 mmol/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236962


Contacts
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Contact: Melissa F Formosa, B Sci +61 9076 1652 m.formosa@alfred.org.au
Contact: Andrew L Carey, PhD +61 8532 1251 andrew.carey@bakeridi.edu.au

Locations
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Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Melissa F Formosa, B Sci    +61 9076 6518    m.formosa@alfred.org.au   
Principal Investigator: Bronwyn A Kingwell, PhD         
Sponsors and Collaborators
Bayside Health
Baker Heart and Diabetes Institute
The Alfred
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT02236962    
Other Study ID Numbers: 15-12
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Cardiovascular Diseases
Pioglitazone
Ephedrine
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action