NCT05294965

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Thermogenesis

Interventions

Type	Name	Description
DRUG	Fenoterol	Intravenous infusion
OTHER	Mild cold exposure	Body surface cooling

Timeline

• Start date: 2022-04-27
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2022-03-24
• Last updated: 2023-09-26

Locations

1 site across 1 country: Switzerland