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NCT Number: NCT01015794

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Alfred Hospital Heart Centre

Prahran, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ephedrine hydrochloride

Drug

single oral dose, 1mg/kg body weight

Primary outcomes

  1. BAT activity via PET-CT

    Time frame: Baseline and 3 weeks

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Important dates

Study start
2009
Primary completion
2012
First posted
Nov 18, 2009
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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