Armolipid Plus and Metabolic Syndrome

Rottapharm

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Armolipid Plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01087632

ARMP-09

Details and patient eligibility

About

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).

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Armolipid Plus

Experimental group

Description:

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

Treatment:

Dietary Supplement: Armolipid Plus

Placebo

Placebo Comparator group

Description:

Placebo matching Armolipid plus

Treatment:

Dietary Supplement: Armolipid Plus