Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue

Early Phase 1CompletedNCT05294965

University Hospital, Basel, Switzerland12 enrolled

Overview

The purpose of the study is to asses brown adipose tissue activity in humans after intravenous administration of the selective beta-2-adrenergic agonist fenoterol as compared to the natural activator of brown adipose tissue, a mild cold stimulus.

The activation of brown adipose tissue in response to beta-2-adrenergic stimulation as compared to cold exposure will be studied in an open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions a) and b): 1. A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose of fenoterol per subject will thus be 145µg. 2. During 120 minutes participants will be exposed to a mild cold stimulus water using cooling sleeves, covering the participant's waist, is gradually decrease body surface temperature to 10 degrees or to the lowest tolerable temperature without shivering. Energy expenditure will be measured during both interventions by indirect calorimetry and brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Thermogenesis

Interventions

FenoterolDRUG

Intravenous infusion

Mild cold exposureOTHER

Body surface cooling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 18,5-23 kg/m2 or 30-35 kg/m2 Exclusion Criteria: * History or signs of any medical or psychological condition * pregnancy or lactation * medications except prescription free analgesics and contraceptives * habitual alcohol or tobacco use * weight change \>5% within prior 3 months * Resting heart rate \>85 bpm * Systolic blood pressure \>140 mmHg or diastolic blood pressure \<50 mmHg * Presence of following ECG changes: ST-segment deviations, QTc \>500ms, signs of pre-excitation * Hyper- or Hypothyroidism * inability to follow study procedures * Enrolment of the investigator, his/her family members, employees and other dependent persons * hypersensitivity to cold * enrolment into study with ionizing radiation within prior 12 months. * Cold induced thermogenesis of less than 5% basal metabolic rate and normal weight or cold induced thermogenesis of more than 5% and overweight (determined during screening visit)

Locations (1)

University Hospital Basel, Dept. of Endocrinology

Basel, Switzerland

Outcomes

Primary Outcomes

BAT SUVmean

18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F-FDG PET-CT after the respective study intervention

Time frame: 30 minutes after end of intervention

Secondary Outcomes

BAT SUVmax

maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0)

Time frame: 30 minutes after intervention

BAT Volume

volume of supraclavicular adipose tissue (according to BARCIST 1.0)

Time frame: 30 minutes after intervention

BAT glycolytic volume

volume of supraclavicular adipose tissue x SUVmean (according to BARCIST 1.0)

Time frame: 30 minutes after intervention

Change in energy expenditure

Quantitative change in EE above resting metabolic rate in response to the respective study intervention. Measured by indirect calorimetry.

Time frame: First and last 30 minutes of intervention

Data from ClinicalTrials.gov

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