Physical and Chemical Study of Atherosclerosis Mechanisms (PCSAM)

October 3, 2012 updated by: Nazarbayev University

Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention

Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical properties of lipid tissues at various localization with subsequent development of concept of treatment and prevention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050000
        • Scientific Research Institute of Cardiology and Internal Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent form
  • dyslipidemia (HDL <1.0 mmol / l, triglycerides (TG) in plasma ≥ 1,7 mmol / l or cholesterol ≥ 5,6 mmol /l)
  • waist circumference ≥ 94.0 cm in men or ≥ 80,0 cm in women,
  • BP ≥140/95 mm Hg or a patient is taking antihypertensive medications,
  • 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

Exclusion Criteria:

  • Absence of consent form
  • Non-compliance of patient to necessary recommendations.
  • The presence of mental illness.
  • Complete immobilization of a patient (paresis, and paralysis).

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional treatment

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.
Drug: Conventional treatment

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.

Other Names:
  • Pathogenetic and symptomatic treatment
EXPERIMENTAL: Weight loss treatment
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.
Dietary supplement: Weight loss treatment
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.
Other Names:
  • vegetable and salt diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
full recovery from atherosclerotic diseases
Time Frame: for 12 months

Regression of atherosclerosis plaque in vessel: imaging methods (GE Vivid 7 Ultrasound; GE Healthcare Worldwide USA, Michigan), and computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).

Improvement of clinical condition: by measurement of clinical presence status.
for 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
normalised laboratory and instrumental data
Time Frame: for 12 month

Weight loss: Tanita-SC330S Body Composition Analyzer (Tanita Corp., Tokyo, Japan) including weight (kg), body mass index (BMI, kg/m2), body composition parameters, including as fat mass (in % of total body weight and total kg), visceral fat rating (units), fat free mass (kg), total body water (in % and kg), muscle mass (in % and kg), bone mass (in % and kg), metabolic age (years), basal metabolic rate (kcal per day), and bioimpedance (Ohms).

Rate of blood circulation: Dopler Ultrasound (GE Healthcare Worldwide USA, Michigan).

Bone density: bone densitometry (Lunar Achilles Express Ultrasound; GE Healthcare USA, Madison).

Imaging of internal organs and blood vessel diameter: computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).

General clinical study of blood and urine, liver and kidneys function tests, glucose and lipids levels.

Clinical condition in dynamics: clinical presence status.
for 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazarbayev University

Collaborators

Ministry of Health, Kazakhstan

Investigators

  • Principal Investigator: Kuat P Oshakbayev, MD, PhD, DsC, Scientisic research institute of cardiology and internal diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0109RK000079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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