Physical and Chemical Study of Atherosclerosis Mechanisms (PCSAM)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Kazakhstan
Information provided by (Responsible Party):
Republican Scientific Center for Emergency Medicine
ClinicalTrials.gov Identifier:
NCT01700075
First received: September 21, 2012
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Coronary Artery Diseases
Diabetes Mellitus, Type 2
Atherosclerosis of Femoral Artery
Drug: Conventional treatment
Dietary Supplement: Weight loss treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention

Resource links provided by NLM:


Further study details as provided by Republican Scientific Center for Emergency Medicine:

Primary Outcome Measures:
  • full recovery from atherosclerotic diseases [ Time Frame: for 12 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • normalised laboratory and instrumental data [ Time Frame: for 12 month ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 97
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: vegetable and salt diet

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.

  Eligibility

Ages Eligible for Study:   26 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700075

Locations
Kazakhstan
Scientific Research Institute of Cardiology and Internal Diseases
Almaty, Kazakhstan, 050000
Sponsors and Collaborators
Republican Scientific Center for Emergency Medicine
Ministry of Health, Kazakhstan
Investigators
Principal Investigator: Kuat P Oshakbayev, MD, PhD, DsC Scientisic research institute of cardiology and internal diseases
  More Information

No publications provided

Responsible Party: Republican Scientific Center for Emergency Medicine
ClinicalTrials.gov Identifier: NCT01700075     History of Changes
Other Study ID Numbers: 0109RK000079
Study First Received: September 21, 2012
Last Updated: October 3, 2012
Health Authority: Kazakhstan: Ethical Commission
Kazakhstan: Ministry of Public Health

Keywords provided by Republican Scientific Center for Emergency Medicine:
atherosclerosis, development of concept, weight loss therapy

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Infarction
Myocardial Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Antihypertensive Agents
Hypoglycemic Agents
Platelet Aggregation Inhibitors
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs
Hematologic Agents

ClinicalTrials.gov processed this record on April 14, 2014