Completed

PCSAMStudy of Atherosclerosis Mechanisms for Treatment and Prevention

Study Aim

This study aims to evaluate the effectiveness of a treatment in achieving full recovery from atherosclerotic diseases, measured by the regression of atherosclerosis plaque in your vessels using imaging methods and improvement in your clinical condition.

What is being tested

Conventional treatment

+ Weight loss treatment

DrugDietary Supplement

Who is being recruted

Arterial Occlusive Diseases+18

+ Arteriosclerosis

+ Cardiovascular Diseases

From 26 to 70 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: January 2009

See protocol details

Summary

Principal SponsorNazarbayev University

Last updated: October 4, 2012

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

The chemical and physical properties of different lipids of body. The clinical part of the work is a prospective randomized comparative controlled clinical trial of patients with atherosclerotic diseases. Developed the concept of "limited biological resources" of the body based on the increase in the expenditure of energy reserves of the body, allowing a critical look at overweight. The role of overweight in the development of atheromatous fat was revealed. The positive results from the weight loss in patients with atherosclerotic disease were drawn. Developed the metabolic concept of atherosclerosis associated with evolutionary aging and conversion of lipids in hard atherosclerotic fat.

NCT01700075

Principal SponsorNazarbayev University

Last updated: October 4, 2012

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

97 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 26 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseDiabetes MellitusEndocrine System DiseasesHeart DiseasesInfarctionIschemiaMetabolic DiseasesNecrosisNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaGlucose Metabolism DisordersCoronary Artery DiseaseDiabetes Mellitus, Type 2Myocardial InfarctionAtherosclerosis

Criteria

6 inclusion criteria required to participate

BP >= 140/95 mm Hg or a patient is taking antihypertensive medications

dyslipidemia (HDL < 1.0 mmol / l, triglycerides (TG) in plasma >= 1,7 mmol / l or cholesterol >= 5,6 mmol /l)

fasting glucose >= 6,1 mmol / l or the patient is taking hypoglycemic agents

the possibility of treatment for 6 months and follow-up for 1 year

Show More Criteria

4 exclusion criteria prevent from participating

Absence of consent form

Complete immobilization of a patient (paresis, and paralysis)

Non-compliance of patient to necessary recommendations

The presence of mental illness

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Lipidlowering: "Atorvastatin" (Liprimar) - 40mg per day. Antihypertensive: "Diroton" (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and "Ditiazem" (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day. Antihyperglycemic drugs: biguanides "Metformin" - 0.5 g two or tree times per day, or "Exenatide" - 5-10 µg per day. Anti-inflammatory: "TromboACC" (acetylsalicylate acid) up to 2 g per day and/or "Clopidogrel" (thienopyridine class antiplatelet agent) - 75mg per day.

Group II

Experimental

Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Scientific Research Institute of Cardiology and Internal Diseases

Almaty, KazakhstanOpen Scientific Research Institute of Cardiology and Internal Diseases in Google Maps

CompletedOne Study Center