A Phase 4 interventional study of Fluvastatin in Adipose Tissue, Brown, Insulin Resistance and Clinical Trial, sponsored by University of Zurich. Completed at 2 sites in Switzerland. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by University of Zurich · Phase 4, Interventional, and Basic science
The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue activity in humans.
Statins, inhibitors of cholesterol biosynthesis, act by inhibiting the enzyme of the mevalonate pathway. Although the clinical benefits of statins are undisputable, they have been shown to increase insulin resistance and incidence of type 2 diabetes mellitus, the mechanism of which is currently not clear.
The main function of brown adipose tissue (BAT) is non-shivering thermogenesis (i.e. heat production through energy dissipation) in brown adipocytes. There has been a growing interest in BAT as a novel therapeutic approach to increase energy expenditure in order to facilitate weight-loss and increase insulin sensitivity.
BAT activity will be assessed using calorimetric test and [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET).
We speculate that statins inhibit BAT function and that this mechanism may contribute to the above mentioned increase in insulin resistance.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 17 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Volunteers receive calorimetric tests and FDG PET scans pre and post 2 weeks of Fluvastatine.
Drug: Fluvastatin
Fluvastatin 40 mg twice daily per mouth for 14 days.
Also known as: Lescol
(18)F-FDG uptake in the supraclavicular brown adipose tissue measured by PET by the maximum standardized uptake value (SUVmax)
Cold and Mirabegron induced 18F-FDG uptake into the supra-clavicular brown adipose tissue (scBAT) as determined by 18F-FDG PET/MR standardized uptake value (SUVmax) after two weeks of treatment with Fluvastatin.
Time frame: 14 days
The mean standardized uptake value for 18F-FDG uptake (SUVmean) in the supraclavicular adipose tissue depot
SUVmean in the supraclavicular adipose tissue depot (analog. SUVmax)
Time frame: 14 days
Volume of supraclavicular BAT
Volume of supraclavicular BAT as determined on Magnetic Resonance Imaging (MRI)
Time frame: 14 days
fat fraction with T2 relaxation time of the BAT depot
fat fraction with T2 relaxation time of the scBAT depot as determined by MRI
Time frame: 14 days
Cold induced thermogenesis
Cold induced thermogenesis: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus and pharmacologic stimulation with Mirabegron.
Time frame: 14 days
Supraclavicular skin temperature in response to mild cold stimulus
Supraclavicular skin temperature in response to mild cold stimulus measured by local probe
Time frame: 14 days
Plan to share: Undecided
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Zurich