Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment

NCT ID: NCT02236962

Last Updated: 2014-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Obesity Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

lactose powder in equivalent capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug treatment

sympathetic agonist and thiazolidinedione

Group Type EXPERIMENTAL

Ephedrine, pioglitazone

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Ephedrine, pioglitazone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baker Heart and Diabetes Institute

OTHER

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Melissa F Formosa, B Sci

Role: CONTACT

+61 9076 1652

Andrew L Carey, PhD

Role: CONTACT

+61 8532 1251

Facility Contacts

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Melissa F Formosa, B Sci

Role: primary

+61 9076 6518

References

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Loh RKC, Formosa MF, Eikelis N, Bertovic DA, Anderson MJ, Barwood SA, Nanayakkara S, Cohen ND, La Gerche A, Reutens AT, Yap KS, Barber TW, Lambert GW, Cherk MH, Duffy SJ, Kingwell BA, Carey AL. Pioglitazone reduces cold-induced brown fat glucose uptake despite induction of browning in cultured human adipocytes: a randomised, controlled trial in humans. Diabetologia. 2018 Jan;61(1):220-230. doi: 10.1007/s00125-017-4479-9. Epub 2017 Oct 18.

Reference Type DERIVED
PMID: 29046921 (View on PubMed)

Carey AL, Pajtak R, Formosa MF, Van Every B, Bertovic DA, Anderson MJ, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Chronic ephedrine administration decreases brown adipose tissue activity in a randomised controlled human trial: implications for obesity. Diabetologia. 2015 May;58(5):1045-54. doi: 10.1007/s00125-015-3543-6. Epub 2015 Mar 1.

Reference Type DERIVED
PMID: 25725625 (View on PubMed)

Other Identifiers

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15-12

Identifier Type: -

Identifier Source: org_study_id

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