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Armolipid Plus and Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Federico II University
Information provided by:
Rottapharm
ClinicalTrials.gov Identifier:
NCT01087632
First received: March 12, 2010
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  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:

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
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
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

No publications provided

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:
Insulin Resistance
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Folic Acid
Vitamin B Complex
Ubiquinone
Coenzyme Q10
Policosanol
Lovastatin
Red yeast rice
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
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 May 23, 2013