Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation

NCT ID: NCT01015794

Last Updated: 2013-02-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Adrenergic agonist

Group Type EXPERIMENTAL

ephedrine hydrochloride

Intervention Type DRUG

single oral dose, 1mg/kg body weight

ephedrine hydrochloride

Intervention Type DRUG

single dose of 1 mg/kg body weight

Interventions

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ephedrine hydrochloride

single oral dose, 1mg/kg body weight

Intervention Type DRUG

ephedrine hydrochloride

single dose of 1 mg/kg body weight

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

Exclusion Criteria

* Unable to give informed consent
* Smokers
* Lactose intolerance


* Unable to give informed consent
* Smokers
* Lactose intolerance
* Participant in research projects involving ionising radiation within the past 5 years
* claustrophobia
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alfred Hospital Heart Centre

Prahran, Victoria, Australia

Site Status

Countries

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Australia

References

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Carey AL, Formosa MF, Van Every B, Bertovic D, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Ephedrine activates brown adipose tissue in lean but not obese humans. Diabetologia. 2013 Jan;56(1):147-55. doi: 10.1007/s00125-012-2748-1. Epub 2012 Oct 13.

Reference Type RESULT
PMID: 23064293 (View on PubMed)

Other Identifiers

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404/09

Identifier Type: -

Identifier Source: org_study_id

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