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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT01015794
First received: October 29, 2009
Last updated: February 12, 2013
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Drug: ephedrine hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • BAT activity via PET-CT [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2009
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adrenergic agonist Drug: ephedrine hydrochloride
single oral dose, 1mg/kg body weight
Drug: ephedrine hydrochloride
single dose of 1 mg/kg body weight

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015794

Locations
Australia, Victoria
Alfred Hospital Heart Centre
Prahran, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
  More Information

Publications:

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT01015794     History of Changes
Other Study ID Numbers: 404/09
Study First Received: October 29, 2009
Last Updated: February 12, 2013
Health Authority: Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Adrenergic Agents
Ephedrine
Pseudoephedrine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Nasal Decongestants
Respiratory System Agents
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on May 16, 2013