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Armolipid Plus and Metabolic Syndrome

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
More Information
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Responsible Party: Massimo D'Amato, MD, Rottapharm
ClinicalTrials.gov Identifier: NCT01087632     History of Changes
Other Study ID Numbers: ARMP-09
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2010

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