Physical and Chemical Study of Atherosclerosis Mechanisms (PCSAM)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Coronary Artery Diseases Diabetes Mellitus, Type 2 Atherosclerosis of Femoral Artery |
Drug: Conventional treatment Dietary Supplement: Weight loss treatment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention |
- full recovery from atherosclerotic diseases [ Time Frame: for 12 months ] [ Designated as safety issue: Yes ]
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.
- normalised laboratory and instrumental data [ Time Frame: for 12 month ] [ Designated as safety issue: Yes ]
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.
| Enrollment: | 97 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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. |
Drug: 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. Other Name: Pathogenetic and symptomatic treatment
|
|
Experimental: 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.
|
Dietary Supplement: 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.
Other Name: vegetable and salt diet
|
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| Ages Eligible for Study: | 26 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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).
Contacts and Locations| Kazakhstan | |
| Scientific Research Institute of Cardiology and Internal Diseases | |
| Almaty, Kazakhstan, 050000 | |
| Principal Investigator: | Kuat P Oshakbayev, MD, PhD, DsC | Scientisic research institute of cardiology and internal diseases |
More Information
No publications provided
| Responsible Party: | Republican Scientific Center for Emergency Medicine |
| ClinicalTrials.gov Identifier: | NCT01700075 History of Changes |
| Other Study ID Numbers: | 0109RK000079 |
| Study First Received: | September 21, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | Kazakhstan: Ethical Commission Kazakhstan: Ministry of Public Health |
Keywords provided by Republican Scientific Center for Emergency Medicine:
|
atherosclerosis, development of concept, weight loss therapy |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Infarction Myocardial Infarction Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Ischemia Pathologic Processes Necrosis Antihypertensive Agents Hypoglycemic Agents Platelet Aggregation Inhibitors Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Physiological Effects of Drugs Hematologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013