Clinical trial NCT01087632: Armolipid Plus and Metabolic Syndrome
Official title: Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome Insulin-resistance Endothelial Function
Lead sponsor: Rottapharm
Sponsor class: INDUSTRY
Collaborators: name: Federico II University
First posted: 2010-03-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Insulin/glucose ratio after overnight fast
timeFrame: 18 weeks
measure: Insuline/glucose ratio after an oralglucose tolerance test
timeFrame: 18 weeks
Secondary outcomes:
measure: BMI
timeFrame: 18 weeks
measure: Glycemia
timeFrame: 18 weeks
measure: Endothelial function
timeFrame: 18 weeks
measure: C reactive protein.
timeFrame: 18 weeks
measure: Serum lipidemia
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University - Department of Internal Medicine
Study officials:
affiliation: Federico II University
name: Serafino Fazio, MD
role: PRINCIPAL_INVESTIGATOR
References: