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

February 12, 2013 updated by: Bayside Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Prahran, Victoria, Australia, 3004
        • Alfred Hospital Heart Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria: healthy group

  • 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

Inclusion Criteria: obese group

  • 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

The inclusion criteria (Obese participants) of body weight less than ~100 kg is implemented as the PET-CT scanner to be utilised (protocol described subsequently) has a limited patient volume. Therefore to fit within the criteria of BMI > 30, only patients of height ~183 cm or less can be recruited, and inclusion of borderline participants will be discussed with co-investigators from the Alfred Hospital Nuclear Medicine Department.

Exclusion Criteria: healthy group

  • Unable to give informed consent
  • Smokers
  • Lactose intolerance

Exclusion Criteria: obese group

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adrenergic agonist
Drug: ephedrine hydrochloride
single oral dose, 1mg/kg body weight
Drug: ephedrine hydrochloride
single dose of 1 mg/kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BAT activity via PET-CT
Time Frame: Baseline and 3 weeks
Baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 404/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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