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Physical and Chemical Study of Atherosclerosis Mechanisms

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01700075
Acronym
PCSAM
Enrollment
97
Registered
2012-10-04
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

atherosclerosis, development of concept, weight loss therapy

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.

Interventions

DRUGConventional 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.

DIETARY_SUPPLEMENTWeight 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.

Sponsors

Ministry of Health, Kazakhstan
CollaboratorOTHER_GOV
Nazarbayev University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
26 Years to 70 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
full recovery from atherosclerotic diseasesfor 12 monthsRegression 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

MeasureTime frameDescription
normalised laboratory and instrumental datafor 12 monthWeight 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.

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026