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

NCT05294965 | Completed Early Phase 1

• 1 other identifier: EKNZ 2022-00037
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thermogenesis

Keywords

brown adipose tissue; beta2-adrenergic agonist; cold exposure

Outcome Measures

Primary Outcomes (1)

• BAT SUVmean

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

  30 minutes after end of intervention

Secondary Outcomes (4)

• BAT SUVmax

  30 minutes after intervention

• BAT Volume

  30 minutes after intervention

• BAT glycolytic volume

  30 minutes after intervention

• Change in energy expenditure

  First and last 30 minutes of intervention

Study Arms (2)

Normal weight

EXPERIMENTAL

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. Mild cold exposure: During 120 minutes the water temperature in cooling sleeves, covering the participant's waist, is gradually decreased to 10 degrees or to the lowest tolerable temperature without shivering.

Drug: Fenoterol; Other: Mild cold exposure

Overweight

EXPERIMENTAL

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. Mild cold exposure: During 120 minutes the water temperature in cooling sleeves, covering the participant's waist, is gradually decreased to 10 degrees or to the lowest tolerable temperature without shivering.

Drug: Fenoterol; Other: Mild cold exposure

Interventions

Fenoterol DRUG

Intravenous infusion

Also known as: beta2 adrenoreceptor agonist

Normal weight; Overweight

Mild cold exposure OTHER

Body surface cooling

Normal weight; Overweight

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18,5-23 kg/m2 or 30-35 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Dept. of Endocrinology

Basel, Switzerland

Location

MeSH Terms

Interventions

Fenoterol

Intervention Hierarchy (Ancestors)

Metaproterenol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Matthias Betz, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 24, 2022
• Study Start: April 27, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)