Policosanol in patients with metabolic syndrome and ischaemic cardiopaty

Phase 4

Conditions: Metabolic Syndrome and ischaemic cardiopaty
Myocardial Ischemia
Oxidative Stress
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nutritional and Metabolic Diseases
Heart Diseases
Vascular Diseases

Registration Number: RPCEC00000227

Lead Sponsor: Center of Natural Products, National Center for Scientific Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

Inclusion Criteria

1) Patients with ischaemic cardiopaty.
2) Both sexes.
3) Age: 25-70 years
4) Diagnostic of metabolic syndrome by NCEP-ATP III criteria

Exclusion Criteria

1) Consuming policosanol or other lipid lowering drug and antioxidant or pro-oxidant medications, six months period previus study.
2) Ischaemic or haemorragic ictus.
3) Mayor surgery six mionths previusat study begining.
4) Cardiac insuficience.
5) Hepatic insuficience.
6) Neoplasms diagnosed.
7) Alcoholism.
8) Psyquiatric problems.
9) Patients with clinical history of allergy to any other medicines or other conditions that endanger their health and their lives during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxidative stress and antioxidant defenses determination:<br>Concentration of Maolondialdehido (MDA) (uM). Measuring time: at baseline, 90 and 180 days of treatment.<br>Concentration of advances products of the oxidation of proteins (PAOP) (uM cloramine). Measuring time: at baseline, 90 and 180 days of treatment. <br>Concentration of total organoperoxides (OT) (uM). Measuring time: at baseline, 90 and 180 days of treatment.<br>Concentration of glutation (GSH) (mg L). Measuring time: at baseline, 90 and 180 days of treatment.<br>Concentration of superoxid dismutase (SOD) (U mL min). Measuring time: at baseline, 90 and 180 days of treatment.<br>Concentration of catalase (CAT) (uM). Measuring time: at baseline, 90 and 180 days of treatment.<br>

Secondary Outcome Measures

Name	Time	Method
Tryglicerides (mmol/L), HDL-C (mmol/L). Measuring time: at baseline, 90 and 180 days of treatment.<br>Risk stratification by total score of Goldman Scale. Measuring time: At baseline, 90 and 180 days of treatment. <br>Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. <br>Laboratory parameters: cholesterol (mmol/L), LDL-C (mmol/L), alcaline phosphatase /U/L), glucose (mmol/L), creatinine (umol/L), ALT (U/L), AST (U/L), total protein (g/L), albumin (g/L), uric acid (mmol/L), urea (mmol/L), apo A (g/L9, apo B (g/L). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment.<br>Adverse Events-AE (Description (AE name), intensity (mild, moderate, severe), causality (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of 45, 90, 135 and 180 days of treatment.