Armolipid Plus and Metabolic Syndrome

NCT ID: NCT01087632

Last Updated: 2010-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-07-31

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).

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Armolipid Plus

Intervention Type: DIETARY_SUPPLEMENT

Armolipid Plus 1 tablet QD for 18 weeks

Placebo

Placebo matching Armolipid plus

Group Type: PLACEBO_COMPARATOR

Armolipid Plus

Intervention Type: DIETARY_SUPPLEMENT

Armolipid Plus 1 tablet QD for 18 weeks

Interventions

Armolipid Plus

Armolipid Plus 1 tablet QD for 18 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

berberine; red yeast rice; monacolin K; policosanol; coenzyme Q10; astaxanthin; folic acid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: collaborator

Rottapharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Rottapharm

Principal Investigators

Serafino Fazio, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Federico II University - Department of Internal Medicine

Naples, Naples, Italy

Countries

Italy

Other Identifiers

ARMP-09

Identifier Type: -

Identifier Source: org_study_id