PCSAM: Physical and Chemical Study of Atherosclerosis Mechanisms

Sponsor

Nazarbayev University (Other)

Overall Status

Completed

CT.gov ID

NCT01700075

Collaborator

Ministry of Health, Kazakhstan (Other)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

full recovery from atherosclerotic diseases [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.

Secondary Outcome Measures

normalised laboratory and instrumental data [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

26 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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