Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 7:04 PM
Study NCT ID:
NCT01087632
Status:
COMPLETED
Last Update Posted:
2010-09-02
First Post:
2010-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Armolipid Plus and Metabolic Syndrome
Sponsor:
Rottapharm
Organization:
Study Overview
Official Title:
Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: