Physical and Chemical Study of Atherosclerosis Mechanisms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2, Atherosclerosis of Femoral Artery

Intervention / Treatment
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* Drug: Conventional treatment
* Dietary Supplement: Weight loss treatment


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>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<br>* 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.<br>* Other names: Pathogenetic and symptomatic treatment;|
| Experimental: Weight loss treatment<br>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<br>* 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.<br>* Other names: vegetable and salt diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| full recovery from atherosclerotic diseases | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerosis, development of concept, weight loss therapy