Brown Adipose Tissue Clinical Trial
— GlucoBATOfficial title:
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
Verified date | June 2019 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 16, 2019 |
Est. primary completion date | April 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel, Department of Endocrinology | Basel | BS |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glucose level before and after mild cold stimulus | at the end of each treatment period (day 7). Prednisone vs. Placebo | ||
Other | FGF21 level before and after mild cold stimulus | at the end of each treatment period (day 7). Prednisone vs. Placebo | ||
Other | Expression levels of genes involved in thermogenesis and white to brown adipose tissue transdifferentiation in supraclavicular adipose tissue. | at the end of each treatment period (day 7). Prednisone vs. Placebo | ||
Primary | Cold induced thermogenesis | : Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus determined by indirect calorimetry | at the end of each treatment period (day 7). Prednisone vs. Placebo | |
Secondary | fat fraction of supraclavicular BAT | determined by MRI | at the end of each treatment period (day 7). Prednisone vs. Placebo | |
Secondary | volume of supraclavicular BAT | determined by MRI | at the end of each treatment period (day 7). Prednisone vs. Placebo | |
Secondary | cold stimulated FGD uptake in brown adipose tissue | determined as SUVmean by FDG-PET/CT | at the end of each treatment period (day 7). Prednisone vs. Placebo | |
Secondary | SUVmax in the supraclavicular adipose tissue depot | determined by FDG-PET/CT | at the end of each treatment period (day 7). Prednisone vs. Placebo |
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