Armolipid Plus and Metabolic Syndrome

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

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).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Armolipid Plus

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • Federico II University - Department of Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Armolipid Plus; Armolipid Plus 1 tablet QD for 18 weeks; Other Names: folic acid; coenzyme Q10; berberine; policosanol; red yeast rice; monacolin K; astaxanthin
Placebo Comparator: Placebo; Placebo matching Armolipid plus	Dietary supplement: Armolipid Plus; Armolipid Plus 1 tablet QD for 18 weeks; Other Names: folic acid; coenzyme Q10; berberine; policosanol; red yeast rice; monacolin K; astaxanthin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rottapharm
• Collaborators: Federico II University
• Investigators: Principal Investigator: Serafino Fazio, MD, Federico II University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 12, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimate): March 16, 2010

Study Record Updates

• Last Update Posted (Estimate): September 2, 2010
• Last Update Submitted That Met QC Criteria: September 1, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Metabolic Syndrome Insulin-resistance Endothelial Function
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Vitamins; Vitamin B Complex; Hematinics; Folic Acid; Coenzyme Q10; Policosanol; Red yeast rice
• Other Study ID Numbers: ARMP-09