Policosanol in patients with metabolic syndrome and ischaemic cardiopaty

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000227
• Date of registration: 27/12/2016
• Prospective Registration: Yes
• Primary sponsor: Center of Natural Products, National Center for Scientific Research
• Public title: Policosanol in patients with metabolic syndrome and ischaemic cardiopaty
• Scientific title: Median term study of the effects of Policosanol in patients with metabolic syndrome and ischaemic cardiopathy - Poli/Pla-SM-CI
• Date of first enrolment: 15/01/2017
• Target sample size: 100
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000227-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
• Phase: 4

Countries of recruitment

Cuba

Contacts

• Name: Julio Cesar Fernandez Travieso
• Affiliation: Center of Natural Products, National Center for Scientific Research

• Name: Sarahi Mendoza Castaño
• Affiliation: Center of Natural products, National Centerfor Scientific Research

Key inclusion & exclusion criteria

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.


Age minimum: 25 years
Age maximum: 70 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Insulin Resistance

Heart Diseases

Vascular Diseases

Glucose Metabolism Disorders

Metabolic Syndrome X

Nutritional and Metabolic Diseases

Oxidative Stress

Metabolic Syndrome and ischaemic cardiopaty

Hyperinsulinism

Cardiovascular Diseases

Metabolic Diseases

Myocardial Ischemia

Intervention(s)

Platelet Aggregation Inhibitors

Fatty Alcohols

Antioxidants

Group 1 (Experimental): 1 tablet of policosanol (10 mg) by oral administration, one daily with food for 6 months.
Group 2 (Control): 1 tablet of placebo by oral administration, once daily with food for 6 months.

Anticholesteremic Agents

Placebos

Hypolipidemic Agents

Tablets

Administration, Oral

Policosanol

Primary Outcome(s)

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

Secondary Outcome(s)

Tryglicerides (mmol/L), HDL-C (mmol/L). Measuring time: at baseline, 90 and 180 days of treatment.
Risk stratification by total score of Goldman Scale. Measuring time: At baseline, 90 and 180 days of treatment.
Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment.
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.
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.

Secondary ID(s)

Poli/Pla-SM

Source(s) of Monetary Support

National Center for Scientific Research Central account for BioCubaFarma

Secondary Sponsor(s)

Dalmer Laboratories