NCT01087632

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 2, 2010

Status Verified

September 1, 2010

Enrollment Period

10 months

First QC Date

March 12, 2010

Last Update Submit

September 1, 2010

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome Insulin-resistance Endothelial Function

Outcome Measures

Primary Outcomes (2)

  • Insulin/glucose ratio after overnight fast

    HOMA INDEX

    18 weeks

  • Insuline/glucose ratio after an oralglucose tolerance test

    OGTT

    18 weeks

Secondary Outcomes (5)

  • BMI

    18 weeks

  • Glycemia

    18 weeks

  • Endothelial function

    18 weeks

  • C reactive protein.

    18 weeks

  • Serum lipidemia

    18 weeks

Study Arms (2)

Armolipid Plus

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo matching Armolipid plus

Dietary Supplement: Armolipid Plus

Interventions

Armolipid PlusDIETARY_SUPPLEMENT

Armolipid Plus 1 tablet QD for 18 weeks

Also known as: berberine, red yeast rice, monacolin K, policosanol, coenzyme Q10, astaxanthin, folic acid
Armolipid PlusPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • pregnancy
  • diabetes mellitus in pharmacologic treatment;
  • hepatic failure;
  • creatininemia \>2 mg/dl;
  • triglyceridemia \> 500 mg/dl;
  • heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University - Department of Internal Medicine

Naples, Naples, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Berberinered yeast riceLovastatinpolicosanolcoenzyme Q10astaxanthineFolic Acid

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPterinsPteridinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Serafino Fazio, MD

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 16, 2010

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 2, 2010

Record last verified: 2010-09

Locations

IT(1)