Armolipid Plus and Metabolic Syndrome

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Armolipid Plus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Armolipid Plus<br>Armolipid Plus is 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 | Dietary Supplement: Armolipid Plus<br>* Armolipid Plus 1 tablet QD for 18 weeks<br>* Other names: folic acid;|
| Placebo Comparator: Placebo<br>Placebo matching Armolipid plus | Dietary Supplement: Armolipid Plus<br>* Armolipid Plus 1 tablet QD for 18 weeks<br>* Other names: folic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin/glucose ratio after overnight fast | HOMA INDEX | 18 weeks | 
| Insuline/glucose ratio after an oralglucose tolerance test | OGTT | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | evaluation of weight and BMI | 18 weeks | 
| Glycemia | Blood Glucose | 18 weeks | 
| Endothelial function | endothelial function assessed by Flow Mediated Dilation | 18 weeks | 
| C reactive protein. | dosage of CRP | 18 weeks | 
| Serum lipidemia | measure of TG and cholesterol | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome Insulin-resistance Endothelial Function