Physical and Chemical Study of Atherosclerosis Mechanisms

Diabetes Mellitus, Type 2 Clinical Trial

— PCSAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700075
• Other study ID #: 0109RK000079
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2012
• Last updated: October 3, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Republican Scientific Center for Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: Ethical CommissionKazakhstan: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 26 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

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.

Locations

Country	Name	City	State
Kazakhstan	Scientific Research Institute of Cardiology and Internal Diseases	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
Republican Scientific Center for Emergency Medicine	Ministry of Health, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Yes
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	Yes