Physical and Chemical Study of Atherosclerosis Mechanisms

NCT ID: NCT01700075

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

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.

Conditions

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

Keywords

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atherosclerosis, development of concept, weight loss therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Weight loss treatment

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pathogenetic and symptomatic treatment vegetable and salt diet

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).
Minimum Eligible Age

26 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Kazakhstan

OTHER_GOV

Sponsor Role collaborator

Nazarbayev University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuat P Oshakbayev, MD, PhD, DsC

Role: PRINCIPAL_INVESTIGATOR

Scientisic research institute of cardiology and internal diseases

Locations

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Scientific Research Institute of Cardiology and Internal Diseases

Almaty, , Kazakhstan

Site Status

Countries

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Kazakhstan

References

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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.

Reference Type DERIVED
PMID: 26608649 (View on PubMed)

Other Identifiers

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0109RK000079

Identifier Type: -

Identifier Source: org_study_id