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Clinical Trial Details

Trial ID: L5398
Source ID: NCT01700075
Associated Drug: Conventional Treatment
Title: Physical and Chemical Study of Atherosclerosis Mechanisms
Acronym: PCSAM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Myocardial Infarction|Coronary Artery Diseases|Diabetes Mellitus, Type 2|Atherosclerosis of Femoral Artery
Interventions: DRUG: Conventional treatment|DIETARY_SUPPLEMENT: Weight loss treatment
Outcome Measures: Primary: 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., for 12 months | Secondary: 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., for 12 month
Sponsor/Collaborators: Sponsor: Nazarbayev University | Collaborators: Ministry of Health, Kazakhstan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 97
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2011-12
Results First Posted:
Last Update Posted: 2012-10-04
Locations: Scientific Research Institute of Cardiology and Internal Diseases, Almaty, 050000, Kazakhstan
URL: https://clinicaltrials.gov/show/NCT01700075