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OpenTrials
Completed

NCT Number: NCT01087632

Armolipid Plus and Metabolic Syndrome

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University - Department of Internal Medicine

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Armolipid Plus

Dietary Supplement

Armolipid Plus 1 tablet QD for 18 weeks

Other names: berberine, red yeast rice, monacolin K, policosanol, coenzyme Q10, astaxanthin, folic acid

Primary outcomes

  1. Insulin/glucose ratio after overnight fast

    Time frame: 18 weeks

    HOMA INDEX

  2. Insuline/glucose ratio after an oralglucose tolerance test

    Time frame: 18 weeks

    OGTT

Secondary outcomes

  1. BMI

    Time frame: 18 weeks

    evaluation of weight and BMI

  2. Glycemia

    Time frame: 18 weeks

    Blood Glucose

  3. Endothelial function

    Time frame: 18 weeks

    endothelial function assessed by Flow Mediated Dilation

  4. C reactive protein.

    Time frame: 18 weeks

    dosage of CRP

  5. Serum lipidemia

    Time frame: 18 weeks

    measure of TG and cholesterol

Sponsors and collaborators

Lead sponsor

Rottapharm

Industry

Collaborators

  • Federico II University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2010
Registry last updated
Sep 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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