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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05294965
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
14.1
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventionsOpen-label, cross-over trial in healthy volunteers with random sequence of the two study interventions
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue
Actual Study Start Date :
Apr 27, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Normal weight

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. 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
Intravenous infusion
Other Names:
  • beta2 adrenoreceptor agonist

    • Other: Mild cold exposure
    Body surface cooling
    Experimental: Overweight

    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. 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
    Intravenous infusion
    Other Names:
  • beta2 adrenoreceptor agonist

    • Other: Mild cold exposure
    Body surface cooling

    Outcome Measures

    Primary Outcome Measures

    1. BAT SUVmean [30 minutes after end of intervention]

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

    Secondary Outcome Measures

    1. BAT SUVmax [30 minutes after intervention]

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

    2. BAT Volume [30 minutes after intervention]

      volume of supraclavicular adipose tissue (according to BARCIST 1.0)

    3. BAT glycolytic volume [30 minutes after intervention]

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

    4. Change in energy expenditure [First and last 30 minutes of intervention]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel, Dept. of Endocrinology Basel Switzerland

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Matthias Betz, MD, University Hospital, Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT05294965
    Other Study ID Numbers:
    • EKNZ 2022-00037
    First Posted:
    Mar 24, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Basel, Switzerland
    brown adipose tissue
    beta2-adrenergic agonist
    cold exposure
    Additional relevant MeSH terms:
    Fenoterol

    Study Results

    No Results Posted as of May 4, 2022