Armolipid Plus and Metabolic Syndrome

Overview

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).

Full Title of Study: “Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2010

Interventions

  • Dietary Supplement: Armolipid Plus
    • Armolipid Plus 1 tablet QD for 18 weeks

Arms, Groups and Cohorts

  • 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
  • Placebo Comparator: Placebo
    • Placebo matching Armolipid plus

Clinical Trial Outcome Measures

Primary Measures

  • Insulin/glucose ratio after overnight fast
    • Time Frame: 18 weeks
    • HOMA INDEX
  • Insuline/glucose ratio after an oralglucose tolerance test
    • Time Frame: 18 weeks
    • OGTT

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rottapharm
  • Collaborator
    • Federico II University
  • Provider of Information About this Clinical Study
    • Massimo D’Amato, MD, Rottapharm
  • Overall Official(s)
    • Serafino Fazio, MD, Principal Investigator, Federico II University

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