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

September 25, 2023 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel, Dept. of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal weight
  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
Intravenous infusion
Other Names:
  • beta2 adrenoreceptor agonist
Other: Mild cold exposure
Body surface cooling
Experimental: Overweight
  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
Intravenous infusion
Other Names:
  • beta2 adrenoreceptor agonist
Other: Mild cold exposure
Body surface cooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BAT SUVmean
Time Frame: 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
30 minutes after end of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BAT SUVmax
Time Frame: 30 minutes after intervention
maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0)
30 minutes after intervention
BAT Volume
Time Frame: 30 minutes after intervention
volume of supraclavicular adipose tissue (according to BARCIST 1.0)
30 minutes after intervention
BAT glycolytic volume
Time Frame: 30 minutes after intervention
volume of supraclavicular adipose tissue x SUVmean (according to BARCIST 1.0)
30 minutes after intervention
Change in energy expenditure
Time Frame: 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.
First and last 30 minutes of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

March 6, 2023

Study Completion (Actual)

March 6, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2022-00037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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