Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis (NCT05711199) | Clinical Trial Compass
CompletedEarly Phase 1
Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis
Switzerland30 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 w…
What they're measuring
1
BAT SUVmean
Timeframe: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively
2
BAT SUVmax
Timeframe: After 14 days treatment with glyceroltrinitrate or after 14 days control period respectively