NCT02295176

Metabolic and Cardiovascular Effects of Armolipid Plus in Subjects With Metabolic Syndrome

Metabolic and Cardiovascular Effects of a Proprietary Nutraceutical Containing Berberine, Policosanols and Red Yeast in Subjects With Metabolic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Rottapharm · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass. 168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial and treated for 24 weeks.

Detailed description

Metabolic syndrome (MetS) 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. A complication of hypertension is hypertrophy of the left ventricle (LV), which is closely related to the incidence of cardiovascular events whose regression results in a proportional reduction of the risk. But also other factors contribute as sex, age, race, genetics, diet and insulin resistance. MetS is closely related to hypertrophy of the LV. Therefore it is possible that the treatment of MetS may be an effective strategy for the prevention of organ damage. Armolipid Plus (an association of berberine 500mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg, coenzyme Q10 2mg,astaxanthin 0,5mg, folic acid 0,2mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on glucose metabolism, myocardial mass and improved diastolic function in subjects with MetS and early organ damage. Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass. 168 patients will be enrolled in this randomized, double-blind, parallel-group, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd). Primary end point will be the reduction of the insulin resistance in patients with metabolic syndrome and increased LV mass.

Conditions

• Metabolic Syndrome
• Insulin-resistance
• Left Ventricular Hypertrophy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Armolipid Plus
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2014-11-20
• Last updated: 2015-10-27

Locations

3 sites across 1 country: Italy