Armolipid Plus and Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Armolipid Plus

• Registration Number: NCT01087632
• Lead Sponsor: Rottapharm

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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).

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Exclusion Criteria

• pregnancy
• diabetes mellitus in pharmacologic treatment;
• hepatic failure;
• creatininemia >2 mg/dl;
• triglyceridemia > 500 mg/dl;
• heart failure.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Armolipid Plus	Armolipid Plus	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
Placebo	Armolipid Plus	Placebo matching Armolipid plus

Primary Outcome Measures

Name	Time	Method
Insulin/glucose ratio after overnight fast	18 weeks	HOMA INDEX
Insuline/glucose ratio after an oralglucose tolerance test	18 weeks	OGTT

Secondary Outcome Measures

Name	Time	Method
BMI	18 weeks	evaluation of weight and BMI
Glycemia	18 weeks	Blood Glucose
Endothelial function	18 weeks	endothelial function assessed by Flow Mediated Dilation
C reactive protein.	18 weeks	dosage of CRP
Serum lipidemia	18 weeks	measure of TG and cholesterol

Trial Locations

Locations (1)

Federico II University - Department of Internal Medicine; 🇮🇹 Naples, Italy