Armolipid Plus and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087632
• Other study ID #: ARMP-09
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: September 1, 2010
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Rottapharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Armolipid Plus
Armolipid Plus 1 tablet QD for 18 weeks

Locations

Country	Name	City	State
Italy	Federico II University - Department of Internal Medicine	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Rottapharm	Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin/glucose ratio after overnight fast	HOMA INDEX	18 weeks	No
Primary	Insuline/glucose ratio after an oralglucose tolerance test	OGTT	18 weeks	No
Secondary	BMI	evaluation of weight and BMI	18 weeks	No
Secondary	Glycemia	Blood Glucose	18 weeks	No
Secondary	Endothelial function	endothelial function assessed by Flow Mediated Dilation	18 weeks	No
Secondary	C reactive protein.	dosage of CRP	18 weeks	No
Secondary	Serum lipidemia	measure of TG and cholesterol	18 weeks	No