Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment

Bayside Health

Status: Unknown

Conditions: Obesity; Type 2 Diabetes; Cardiovascular Disease

Treatments: Drug: Ephedrine, pioglitazone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02236962

15-12

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: Male

Ages: 19 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

lactose powder in equivalent capsule

Treatment:

Drug: Placebo

Drug treatment

Experimental group

Description:

sympathetic agonist and thiazolidinedione

Treatment:

Drug: Ephedrine, pioglitazone