ThermogenesisEarly Phase 1ASCENTNCT05294965
Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue
A Early Phase 1 study testing Fenoterol and Mild cold exposure in people with Thermogenesis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thermogenesis
- What is being tested?
- Fenoterol and Mild cold exposure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Apr 2022to 6 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18,5-23 kg/m2 or 30-35 kg/m2
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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):
- 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.
- 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
- Being tested
- Fenoterol, Mild cold exposure
- Keywords
- brown adipose tissue, beta2-adrenergic agonist, cold exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenoterolDrug
Also called beta2 adrenoreceptor agonist
Intravenous infusion
Mild cold exposureOther
Body surface cooling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fenoterol; Other: Mild cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT SUVmean
18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F-FDG PET-CT after the respective study intervention
Measured: 30 minutes after end of intervention
Secondary outcomes (4)
BAT SUVmax
maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0)
Measured: 30 minutes after intervention
BAT Volume
volume of supraclavicular adipose tissue (according to BARCIST 1.0)
Measured: 30 minutes after intervention
BAT glycolytic volume
volume of supraclavicular adipose tissue x SUVmean (according to BARCIST 1.0)
Measured: 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.
Measured: First and last 30 minutes of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start27 Apr 2022
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermogenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Betz, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294965
- Sponsor's protocol ID
- EKNZ 2022-00037
- Acronym
- ASCENT
- Status last verified
- Sep 2023
- First submitted
- 9 Feb 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue
- ClinicalTrials.gov ID
- NCT05294965
- Acronym / sponsor ID
- ASCENT / EKNZ 2022-00037
- Conditions
- Thermogenesis
- Keywords
- brown adipose tissue, beta2-adrenergic agonist, cold exposure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Experimental | Drug: Fenoterol, Other: Mild cold exposure1. 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. |
| Overweight | Experimental | Drug: Fenoterol, Other: Mild cold exposure1. 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18,5-23 kg/m2 or 30-35 kg/m2
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenoterolAlso: beta2 adrenoreceptor agonistIntravenous infusion | Drug | Normal weight, Overweight |
| Mild cold exposureBody surface cooling | Other | Normal weight, Overweight |
Primary outcome
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
4 secondary outcomes
BAT SUVmax
Time frame: 30 minutes after intervention
BAT Volume
Time frame: 30 minutes after intervention
BAT glycolytic volume
Time frame: 30 minutes after intervention
Change in energy expenditure
Time frame: First and last 30 minutes of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Betz, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fenoterol and Mild cold exposure in people with Thermogenesis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAT SUVmean (time frame: 30 minutes after end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.