Federico II University - Department of Internal Medicine
Naples, Italy
NCT Number: NCT01087632
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).
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Naples, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm(F), and two or more of these criteria:
Exclusion criteria
Armolipid Plus 1 tablet QD for 18 weeks
Other names: berberine, red yeast rice, monacolin K, policosanol, coenzyme Q10, astaxanthin, folic acid
Time frame: 18 weeks
HOMA INDEX
Time frame: 18 weeks
OGTT
Time frame: 18 weeks
evaluation of weight and BMI
Time frame: 18 weeks
Blood Glucose
Time frame: 18 weeks
endothelial function assessed by Flow Mediated Dilation
Time frame: 18 weeks
dosage of CRP
Time frame: 18 weeks
measure of TG and cholesterol
Rottapharm
Industry
Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
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