Armolipid Plus and Metabolic Syndrome

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

Tracking Information

• First Submitted Date: March 12, 2010
• First Posted Date: March 16, 2010
• Last Update Posted Date: September 2, 2010
• Study Start Date: September 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Armolipid Plus and Metabolic Syndrome
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Metabolic Syndrome

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 1, 2010): 66
• Original Estimated Enrollment (submitted: March 15, 2010): 60
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01087632
• Other Study ID Numbers: ARMP-09
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Massimo D'Amato, MD, Rottapharm
• Study Sponsor: Rottapharm
• Collaborators: Federico II University

Investigators

• Principal Investigator: Serafino Fazio, MD; Federico II University

• PRS Account: Rottapharm
• Verification Date: September 2010