Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans (NCT03269747) | Clinical Trial Compass
CompletedPhase 4
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
Switzerland16 participantsStarted 2017-12-06
Plain-language summary
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
Who can participate
Age range18 Years – 40 Years
SexMALE
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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:
* Healthy male volunteers
* BMI between 19-27 kg/m2
Exclusion Criteria:
* Cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit)
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* History of depressive disorder, anxiety disorder
* History of tuberculosis or latent infection
* Increased intraocular pressure
* History of peptic / gastrointestinal ulcer disease
* Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), other glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
* Hypersensitivity to cold (e.g. Raynaud Syndrome)
* Allergy to local anesthetic
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Hypothyroidism without sufficient substitution
* Claustrophobia
* MRI incompatible implants
* Enrolment into another study using ionizing radiation within the previous 12 months.
What they're measuring
1
Cold induced thermogenesis
Timeframe: at the end of each treatment period (day 7). Prednisone vs. Placebo