Armolipid Plus and Metabolic Syndrome
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Purpose
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).
| Condition | Intervention |
|---|---|
| Metabolic Syndrome | Dietary Supplement: Armolipid Plus |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome |
- 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
- 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
| Enrollment: | 66 |
| Study Start Date: | September 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Dietary Supplement: Armolipid Plus
Armolipid Plus 1 tablet QD for 18 weeks
Other Names:
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Placebo Comparator: Placebo
Placebo matching Armolipid plus
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Dietary Supplement: Armolipid Plus
Armolipid Plus 1 tablet QD for 18 weeks
Other Names:
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Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087632
| Italy | |
| Federico II University - Department of Internal Medicine | |
| Naples, Italy | |
| Principal Investigator: | Serafino Fazio, MD | Federico II University - Naples (Italy) |
More Information
| Responsible Party: | Massimo D'Amato, MD, Rottapharm |
| ClinicalTrials.gov Identifier: | NCT01087632 History of Changes |
| Other Study ID Numbers: |
ARMP-09 |
| First Submitted: | March 12, 2010 |
| First Posted: | March 16, 2010 |
| Last Update Posted: | September 2, 2010 |
| Last Verified: | September 2010 |
Keywords provided by Rottapharm:
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Metabolic Syndrome Insulin-resistance Endothelial Function |
Additional relevant MeSH terms:
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Syndrome Metabolic Syndrome X Insulin Resistance Disease Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Folic Acid Ubiquinone Coenzyme Q10 Red yeast rice Lovastatin L 647318 Dihydromevinolin |
Policosanol Hematinics Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Platelet Aggregation Inhibitors |