Armolipid Plus and Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT01087632
• Recruitment Status: Completed
• First Posted: March 16, 2010
• Last Update Posted: September 2, 2010
• Sponsor: Rottapharm
• Collaborator: Federico II University
• Information provided by: Rottapharm

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Dietary Supplement: Armolipid Plus	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
• Study Start Date: September 2009
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

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: berberine; red yeast rice; monacolin K; policosanol; coenzyme Q10; astaxanthin; folic acid
Placebo Comparator: Placebo; Placebo matching Armolipid plus	Dietary Supplement: Armolipid Plus; Armolipid Plus 1 tablet QD for 18 weeks; Other Names: berberine; red yeast rice; monacolin K; policosanol; coenzyme Q10; astaxanthin; folic acid

Outcome Measures

Primary Outcome Measures :

1. Insulin/glucose ratio after overnight fast [ Time Frame: 18 weeks ]
   HOMA INDEX
2. Insuline/glucose ratio after an oralglucose tolerance test [ Time Frame: 18 weeks ]
   OGTT

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Italy

Federico II University - Department of Internal Medicine

Naples, Italy

Sponsors and Collaborators

Rottapharm

Federico II University

Investigators

• Principal Investigator: Serafino Fazio, MD; Federico II University

More Information

• Responsible Party: Massimo D'Amato, MD, Rottapharm
• ClinicalTrials.gov Identifier: NCT01087632
• Other Study ID Numbers: ARMP-09
• First Posted: March 16, 2010
• Last Update Posted: September 2, 2010
• Last Verified: September 2010

Keywords provided by Rottapharm:

Metabolic Syndrome Insulin-resistance Endothelial Function

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Folic Acid; Coenzyme Q10; Policosanol; Red yeast rice; Hematinics; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Platelet Aggregation Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors