Status:
COMPLETED
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Brown Adipose Tissue
Eligibility:
MALE
18-40 years
Phase:
PHASE4
Brief Summary
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
Detailed Description
Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults. Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use of glucocortic...
Eligibility Criteria
Inclusion
- Healthy male volunteers
- BMI between 19-27 kg/m2
Exclusion
- 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.
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03269747
Start Date
December 6 2017
End Date
April 16 2019
Last Update
June 5 2019
Active Locations (1)
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1
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, Switzerland, 4031