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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

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date September 2, 2010
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Armolipid Plus and Metabolic Syndrome
Official Title  ICMJE Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Armolipid Plus
  • Placebo Comparator: Placebo
    Placebo matching Armolipid plus
    Intervention: Dietary Supplement: Armolipid Plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2010)
66
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2010)
60
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087632
Other Study ID Numbers  ICMJE ARMP-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Massimo D'Amato, MD, Rottapharm
Study Sponsor  ICMJE Rottapharm
Collaborators  ICMJE Federico II University
Investigators  ICMJE
Principal Investigator: Serafino Fazio, MD Federico II University
PRS Account Rottapharm
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP