Metabolic Syndrome Clinical Trial
Official title:
Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
Metabolic syndrome is a highly prevalent condition characterized by visceral obesity,
abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular
events. Such findings appear to be associated with a decrease in insulin sensitivity.
Management of metabolic syndrome is currently aimed at treating individual components of the
disease without addressing this underlying pathophysiologic mechanism; this translates into
multidrug regimens, high costs and patient compliance issues.
Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin
K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found
to be effective at reducing blood cholesterol and triglycerides, and at improving
endothelial function; subgroup analyses also suggested a benefit on indices of insulin
resistance.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on
the diagnostic parameters of metabolic syndrome.
60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial;
active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin/glucose ratio, both after overnight
fast (HOMA index) and after an oral glucose tolerance test (OGTT).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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