Metabolic Syndrome
Conditions
Keywords
Metabolic Syndrome Insulin-resistance Endothelial Function
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTArmolipid Plus
Armolipid Plus 1 tablet QD for 18 weeks
Sponsors
Federico II University
Rottapharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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: * fasting blood glucose \>100 mg; * systolic blood pressure \>135 or diastolic blood pressure \>85 mmHg or patients in treatment with antihypertensive drugs; * triglyceridemia \>150 mg/dl; * HDL cholesterolemia \< 40 mg/dl(M), \< 50 mg/dl(F).
Exclusion criteria
* pregnancy * diabetes mellitus in pharmacologic treatment; * hepatic failure; * creatininemia \>2 mg/dl; * triglyceridemia \> 500 mg/dl; * heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin/glucose ratio after overnight fast | 18 weeks | HOMA INDEX |
| Insuline/glucose ratio after an oralglucose tolerance test | 18 weeks | OGTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | 18 weeks | endothelial function assessed by Flow Mediated Dilation |
| BMI | 18 weeks | evaluation of weight and BMI |
| Serum lipidemia | 18 weeks | measure of TG and cholesterol |
| C reactive protein. | 18 weeks | dosage of CRP |
| Glycemia | 18 weeks | Blood Glucose |
Countries
Italy
Outcome results
None listed