Clinical trial NCT01700075: Physical and Chemical Study of Atherosclerosis Mechanisms
Official title: Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Coronary Artery Diseases
Diabetes Mellitus, Type 2
Atherosclerosis of Femoral Artery
Keywords: atherosclerosis, development of concept, weight loss therapy
Lead sponsor: Nazarbayev University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Kazakhstan
First posted: 2012-10-04
Enrollment: 97
Sex: ALL
Minimum age (years): 26
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: full recovery from atherosclerotic diseases
timeFrame: for 12 months
Secondary outcomes:
measure: normalised laboratory and instrumental data
timeFrame: for 12 month
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Scientific Research Institute of Cardiology and Internal Diseases
Study officials:
affiliation: Scientisic research institute of cardiology and internal diseases
name: Kuat P Oshakbayev, MD, PhD, DsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oshakbayev K, Dukenbayeva B, Otarbayev N, Togizbayeva G, Tabynbayev N, Gazaliyeva M, Idrisov A, Oshakbayev P. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial. Nutr J. 2015 Nov 25;14:120. doi: 10.1186/s12937-015-0108-y.