A Phase 4 interventional study of Prednisone and Placebo in Brown Adipose Tissue, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Basic science
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
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 glucocorticoids (GCs) is widespread in clinical practice due to their high anti-inflammatory efficacy. While short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance.
In line with these well-known side-effects of GCs, several in vitro studies and animal models demonstrate an inhibiting effect of GCs on BAT thermogenesis.
University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.
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Prednisone 40 mg daily for 7 days
Drug: Prednisone
Placebo daily for 7 days
Drug: Placebo
2 tablets of Prednisone 20 Mg in the morning
2 Placebo tablets in the morning
Cold induced thermogenesis
: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus determined by indirect calorimetry
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
fat fraction of supraclavicular BAT
determined by MRI
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
volume of supraclavicular BAT
determined by MRI
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
cold stimulated FGD uptake in brown adipose tissue
determined as SUVmean by FDG-PET/CT
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
SUVmax in the supraclavicular adipose tissue depot
determined by FDG-PET/CT
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
Glucose level before and after mild cold stimulus
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
FGF21 level before and after mild cold stimulus
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
Expression levels of genes involved in thermogenesis and white to brown adipose tissue transdifferentiation in supraclavicular adipose tissue.
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
Ran from Dec 2017 to primary completion in Apr 2019, 16 months.
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Studies of the drug tested here: Prednisone
University Hospital, Basel, Switzerland →