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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015794
• Other study ID #: 404/09
• Status: Completed
• Phase: N/A
• First received: October 29, 2009
• Last updated: February 12, 2013
• Start date: December 2009

Study information

• Verified date: November 2009
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• ephedrine hydrochloride
single oral dose, 1mg/kg body weight
• ephedrine hydrochloride
single dose of 1 mg/kg body weight

Locations

Country	Name	City	State
Australia	Alfred Hospital Heart Centre	Prahran	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BAT activity via PET-CT		Baseline and 3 weeks	No