Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment

Obesity Clinical Trial

Official title:

Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02236962
• Other study ID #: 15-12
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2012
• Last updated: September 9, 2014
• Start date: April 2012

Study information

• Verified date: September 2014
• Source: Bayside Health
• Contact: Melissa F Formosa, B Sci
• Phone: +61 9076 1652
• Email: m.formosa[@]alfred.org.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Placebo

• Ephedrine, pioglitazone

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Bayside Health	Baker IDI Heart and Diabetes Institute, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brown adipose tissue activity	measured via PET-CT	3 years	No