← Back to all trials
Not Yet Recruiting
NCT05711199
Effect of Glyceroltrinitrate on Human Energy Expenditure and Brown Adipose Tissue Thermogenesis
Conditions: Brown Adipose Tissue
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Phase: EARLY_PHASE1
Enrollment: 25
Sponsor: University Hospital, Basel, Switzerland
Location: Switzerland
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.
Eligibility Criteria
Inclusion Criteria:BMI 18.5 to 25 kg/m2 or 30 to 35kg/m2Able to give informed consent as documented by signatureAge 18 to 40 yearsExclusion Criteria:Contraindications to glyceroltrinitrate, e.g.
known hypersensitivity or allergyConcomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin, PDE-5-inhibitorsClinically 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-syncopeBlood pressure values below 100 mmHg systolic and 60 mmHg diastolicAllergy to local anestheticHypothyroidism without sufficient substitutionHyperthyroidismClaustrophobiaSmoker / habitual tobacco useHabitual excessive alcohol useWeight change of >5% within 3 months prior to inclusionKnown or suspected non-compliance, drug or alcohol abuseInability to follow the procedures of the study, e.g.
due to language problems, psychological disorders, dementia, etc. of the participantEnrolment of the investigator, his/her family members, employees and other dependent personsEnrolment into another study using ionizing radiation within the previous 12 monthsPregnant or lactating womenLab parametersHb below lower reference limitGlycated Hemoglobin (HbA1c): above 6.0%Random plasma glucose >11 mM
Source: ClinicalTrials.gov (NCT05711199). StuddyBuddy aggregates publicly available trial information.