Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical and Chemical Study of Atherosclerosis Mechanisms (PCSAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01700075
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Collaborator:
Ministry of Health, Kazakhstan
Information provided by (Responsible Party):
Nazarbayev University Medical Center

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date October 4, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
full recovery from atherosclerotic diseases [ Time Frame: for 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
normalised laboratory and instrumental data [ Time Frame: for 12 month ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical and Chemical Study of Atherosclerosis Mechanisms
Official Title  ICMJE Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Coronary Artery Diseases
  • Diabetes Mellitus, Type 2
  • Atherosclerosis of Femoral Artery
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Conventional 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.
    Intervention: Dietary Supplement: Weight loss treatment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2012)
97
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 26 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700075
Other Study ID Numbers  ICMJE 0109RK000079
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nazarbayev University Medical Center
Study Sponsor  ICMJE Nazarbayev University Medical Center
Collaborators  ICMJE Ministry of Health, Kazakhstan
Investigators  ICMJE
Principal Investigator: Kuat P Oshakbayev, MD, PhD, DsC Scientisic research institute of cardiology and internal diseases
PRS Account Nazarbayev University Medical Center
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP