Physical and Chemical Study of Atherosclerosis Mechanisms (PCSAM)

Nazarbayev University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Conventional treatment; Dietary Supplement: Weight loss treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01700075

0109RK000079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 26 to 70 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Conventional treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Conventional treatment

Weight loss treatment

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Weight loss treatment