Back to resultsPhysical and Chemical Study of Atherosclerosis Mechanisms (PCSAM)
Primary Purpose
Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Kazakhstan
Study Type
Interventional
Intervention
Conventional treatment
Weight loss treatment
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring atherosclerosis, development of concept, weight loss therapy
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).
Sites / Locations
- Scientific Research Institute of Cardiology and Internal Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment
Weight loss treatment
Arm Description
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 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.
Outcomes
Primary Outcome Measures
full recovery from atherosclerotic diseases
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
normalised laboratory and instrumental data
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.
Full Information
NCT ID
NCT01700075
First Posted
September 21, 2012
Last Updated
October 3, 2012
Sponsor
Nazarbayev University
Collaborators
Ministry of Health, Kazakhstan
1. Study Identification
Unique Protocol Identification Number
NCT01700075
Brief Title
Physical and Chemical Study of Atherosclerosis Mechanisms
Acronym
PCSAM
Official Title
Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nazarbayev University
Collaborators
Ministry of Health, Kazakhstan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2, Atherosclerosis of Femoral Artery
Keywords
atherosclerosis, development of concept, weight loss therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Weight loss treatment
Arm Type
Experimental
Arm Description
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
Drug
Intervention Name(s)
Conventional treatment
Other Intervention Name(s)
Pathogenetic and symptomatic treatment
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Weight loss treatment
Other Intervention Name(s)
vegetable and salt diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
full recovery from atherosclerotic diseases
Description
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.
Time Frame
for 12 months
Secondary Outcome Measure Information:
Title
normalised laboratory and instrumental data
Description
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.
Time Frame
for 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuat P Oshakbayev, MD, PhD, DsC
Organizational Affiliation
Scientisic research institute of cardiology and internal diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scientific Research Institute of Cardiology and Internal Diseases
City
Almaty
ZIP/Postal Code
050000
Country
Kazakhstan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26608649
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.
Results Reference
derived
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Physical and Chemical Study of Atherosclerosis Mechanisms
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