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

March 12, 2010
September 1, 2010
September 2009
July 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01087632 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Armolipid Plus and Metabolic Syndrome
Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Metabolic Syndrome
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01087632
ARMP-09
No
Massimo D'Amato, MD, Rottapharm
Rottapharm
Federico II University
Principal Investigator: Serafino Fazio, MD Federico II University - Naples (Italy)
Rottapharm
September 2010

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