Brown Adipose TissueEarly Phase 1NEXTNCT05711199
Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis
A Early Phase 1 study testing Glyceroltrinitrat in people with Brown Adipose Tissue, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the efficacy of glyceroltrinitrate (Nitroderm® TTS) to activate and expand human BAT as compared to mild cold exposure. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue
- What is being tested?
- Glyceroltrinitrat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 30 Jun 2025
- 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 to 25 kg/m2 or 30 to 35kg/m2
- Able to give informed consent as documented by signature
- Age 18 to 40 years
Who cannot join
- Contraindications to glyceroltrinitrate, e.g. known hypersensitivity or allergy
- Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin, PDE-5-inhibitors
- Clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
- Hypersensitivity to cold (e.g. Raynaud Syndrome)
- Orthostatic hypotension: systolic blood pressure decreases min. 20mmHg or diastolic blood pressure decreases min 10mmHg within 3-5min after standing up (Schellong Test at screening visit)
- History of orthostatic syncope or pre-syncope
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- Blood pressure values below 100 mmHg systolic and 60 mmHg diastolic
- Allergy to local anesthetic
- Hypothyroidism without sufficient substitution
- Hyperthyroidism
- Claustrophobia
- Smoker / habitual tobacco use
- Habitual excessive alcohol use
- Weight change of >5% within 3 months prior to inclusion
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Enrolment into another study using ionizing radiation within the previous 12 months
- Pregnant or lactating women
- Lab parameters
- Hb below lower reference limit
- Glycated Hemoglobin (HbA1c): above 6.0%
- Random plasma glucose >11 mM
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
About this study
The aim of this study is to evaluate the efficacy of glyceroltrinitrate (Nitroderm® TTS) to activate and expand human BAT as compared to mild cold exposure.
Read the detailed description
The activation of brown adipose tissue in response to glyceroltrinitrate 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 periods (treatment and control) seperated by a washout period of 7 days.
In the treatment phase all participants will receive Nitroderm® TTS (glyceroltrinitrate) for a total of 15 days. For better tolerability, it will be will started with a lower dose of 5mg/24h (Nitroderm® TTS) the first 5 days and after that a change to Nitroderm® TTS 10mg/24h for another 10 days will be done. Each transdermal patch will be applied for 12 hours per day (overnight) to avoid development of nitrate tolerance.
Energy expenditure will be measured by indirect calorimetry before and after a mild cold exposure by placing a medical cooling system around their midsection. Additionally brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG. To analyse changes in BAT and muscle which are caused by glyceroltrinitrate as compared with cold stimulus, a tissue biopsie of supraclavicular BAT and skeletal muscle (musculus vastus lateralis) will be performed.
To measure changes in glucose tolerance and triglyceride levels a mixed meal test will be performed during control and treatment phase respectively. Additionally, a indirect calorimetry will be conducted before and after mixed meal test to assess diet-induced thermogenesis, i.e. the increase in REE due to ingestion of nutrients
In control phase the same examinations will be performed, but without glyceroltrinitrat.
- Conditions
- Brown Adipose Tissue
- Being tested
- Glyceroltrinitrat
- Keywords
- energy expenditure, glyceroltrinitrate, cold exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyceroltrinitratDrug
transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 1. administration of glyceroltrinitrate (Nitroderm TTS) for 15 days.
2. measurement of energy expenditure before and after cold exposure
3. performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle)
4. measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. Receives: Drug: Glyceroltrinitrat |
| Control | No intervention | 1. measurement of energy expenditure before and after cold exposure 2. performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) 3. measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. |
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-
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
BAT SUVmax
maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0)
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Secondary outcomes (6)
BAT Volume
volume of supraclavicular adipose tissue (according to BARCIST 1.0)
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
BAT glycolytic volume
volume of supraclavicular adipose tissue x SUVmean (according to BARCIST 1.0)
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Energy expenditure
Quantitative change in EE above resting metabolic rate in response to the respective study intervention. Measured by indirect calorimetry.
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Cold induced thermogenesis
rise in energy expenditure above baseline occurring during mild cold exposure
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Mixed meal test
Changes in glucose tolerance and triglyceride levels after a mixed meal test in the respective study visit.
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Skin temperature
- Changes in skin temperature and body core temperature during treatment with glyceroltrinitrate (Nitroderm® TTS) compared to control.
Measured: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Mar 2023
- Primary completion11 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brown Adipose TissueStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias J Betz, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711199
- Sponsor's protocol ID
- NEXT Study
- Acronym
- NEXT
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2023
- Last updated
- 29 Jul 2025
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis
- ClinicalTrials.gov ID
- NCT05711199
- Acronym / sponsor ID
- NEXT / NEXT Study
- Conditions
- Brown Adipose Tissue
- Keywords
- energy expenditure, glyceroltrinitrate, cold exposure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Feb 2023 (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 aim of this study is to evaluate the efficacy of glyceroltrinitrate (Nitroderm® TTS) to activate and expand human BAT as compared to mild cold exposure.
Detailed description
The activation of brown adipose tissue in response to glyceroltrinitrate 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 periods (treatment and control) seperated by a washout period of 7 days.
In the treatment phase all participants will receive Nitroderm® TTS (glyceroltrinitrate) for a total of 15 days. For better tolerability, it will be will started with a lower dose of 5mg/24h (Nitroderm® TTS) the first 5 days and after that a change to Nitroderm® TTS 10mg/24h for another 10 days will be done. Each transdermal patch will be applied for 12 hours per day (overnight) to avoid development of nitrate tolerance.
Energy expenditure will be measured by indirect calorimetry before and after a mild cold exposure by placing a medical cooling system around their midsection. Additionally brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG. To analyse changes in BAT and muscle which are caused by glyceroltrinitrate as compared with cold stimulus, a tissue biopsie of supraclavicular BAT and skeletal muscle (musculus vastus lateralis) will be performed.
To measure changes in glucose tolerance and triglyceride levels a mixed meal test will be performed during control and treatment phase respectively. Additionally, a indirect calorimetry will be conducted before and after mixed meal test to assess diet-induced thermogenesis, i.e. the increase in REE due to ingestion of nutrients
In control phase the same examinations will be performed, but without glyceroltrinitrat.
Study design
- Primary purpose
- Basic science
- Allocation
- 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 |
|---|---|---|
| Treatment | Experimental | Drug: Glyceroltrinitrat1. administration of glyceroltrinitrate (Nitroderm TTS) for 15 days. 2. measurement of energy expenditure before and after cold exposure 3. performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) 4. measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. |
| Control | No intervention | –1. measurement of energy expenditure before and after cold exposure 2. performing FDG-PET/CT and tissue biopsy (brown adipose tissue and muscle) 3. measurement of glucose tolerance, triglyceride levels and energy expenditure before and after a mixed meal test. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18.5 to 25 kg/m2 or 30 to 35kg/m2
- Able to give informed consent as documented by signature
- Age 18 to 40 years
Key exclusion criteria (23 listed)
- Contraindications to glyceroltrinitrate, e.g. known hypersensitivity or allergy
- Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin, PDE-5-inhibitors
- Clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
- Hypersensitivity to cold (e.g. Raynaud Syndrome)
- Orthostatic hypotension: systolic blood pressure decreases min. 20mmHg or diastolic blood pressure decreases min 10mmHg within 3-5min after standing up (Schellong Test at screening visit)
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 |
|---|---|---|
| Glyceroltrinitrattransdermal patch | Drug | Treatment |
Primary outcome
BAT SUVmean
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F-
BAT SUVmax
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0)
6 secondary outcomes
BAT Volume
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
BAT glycolytic volume
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Energy expenditure
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Cold induced thermogenesis
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Mixed meal test
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
Skin temperature
Time frame: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
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 29 Jul 2025.
- 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 J 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 Glyceroltrinitrat in people with Brown Adipose Tissue, 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 3 inclusion and 23 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 29 Jul 2025. 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: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively). The study lists 2 primary outcomes in all. 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 29 Jul 2025.