Armolipid Plus and Metabolic Syndrome - Full Text View

Purpose

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	Intervention
Metabolic Syndrome	Dietary Supplement: Armolipid Plus


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Folic Acid Metabolic Syndrome

Drug Information available for: Folic acid Vitamin B Complex Lovastatin Candida albicans

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Rottapharm:

Primary Outcome Measures:

Insulin/glucose ratio after overnight fast [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
HOMA INDEX
Insuline/glucose ratio after an oralglucose tolerance test [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
OGTT

Secondary Outcome Measures:

BMI [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
evaluation of weight and BMI
Glycemia [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Blood Glucose
Endothelial function [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
endothelial function assessed by Flow Mediated Dilation
C reactive protein. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
dosage of CRP
Serum lipidemia [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
measure of TG and cholesterol


Enrollment:	66
Study Start Date:	September 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087632

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 - Naples (Italy)

More Information


Responsible Party:	Massimo D'Amato, MD, Rottapharm
ClinicalTrials.gov Identifier:	NCT01087632 History of Changes
Other Study ID Numbers:	ARMP-09
Study First Received:	March 12, 2010
Last Updated:	September 1, 2010
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Rottapharm:


Metabolic Syndrome Insulin-resistance Endothelial Function

Additional relevant MeSH terms:


Syndrome Metabolic Syndrome X Insulin Resistance Disease Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Folic Acid Ubiquinone Coenzyme Q10 Red yeast rice Lovastatin L 647318 Dihydromevinolin	Policosanol Hematinics Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016