Physical and Chemical Study of Atherosclerosis Mechanisms

Phase 4

Completed

• Conditions: Atherosclerosis of Femoral Artery; Diabetes Mellitus, Type 2; Myocardial Infarction; Coronary Artery Diseases
• Interventions: Dietary Supplement: Weight loss treatment; Drug: Conventional treatment

• Registration Number: NCT01700075
• Lead Sponsor: Nazarbayev University

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.

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2011-12
• Study First Submitted: 2012-09-21
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss treatment	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.
Conventional treatment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Scientific Research Institute of Cardiology and Internal Diseases; 🇰🇿 Almaty, Kazakhstan