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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015794

Enrollment

Registered

2009-11-18

Start date

2009-12-31

Completion date

Unknown

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief 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.

Interventions

DRUGephedrine hydrochloride

single oral dose, 1mg/kg body weight

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
BAT activity via PET-CT	Baseline and 3 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026