Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans

• Status: Completed
• Trial end date: 2019-04-16
• Target enrollment: 0
• Participant gender: Male

Summary

Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Glucocorticoids; Prednisone

Criteria

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.