Physical and Chemical Study of Atherosclerosis Mechanisms

NCT01700075 | Completed Phase 4 DMC

• 1 other identifier: 0109RK000079
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Coronary Artery Diseases; Diabetes Mellitus, Type 2; Atherosclerosis of Femoral Artery

Keywords

atherosclerosis, development of concept, weight loss therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• normalised laboratory and instrumental data

  for 12 month

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

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

Weight loss treatment

EXPERIMENTAL

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

Interventions

Conventional treatment DRUG

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.

Also known as: Pathogenetic and symptomatic treatment

Conventional treatment

Weight loss treatment DIETARY_SUPPLEMENT

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.

Also known as: vegetable and salt diet

Weight loss treatment

Eligibility Criteria

• Age: 26 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Absence of consent form
• Non-compliance of patient to necessary recommendations.
• The presence of mental illness.
• Complete immobilization of a patient (paresis, and paralysis).

Sponsors & Collaborators

• Nazarbayev University: lead
• Ministry of Health, Kazakhstan: collaborator

Study Sites (1)

Scientific Research Institute of Cardiology and Internal Diseases

Almaty, 050000, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 26608649 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; Diabetes Mellitus, Type 2; Atherosclerosis

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kuat P Oshakbayev, MD, PhD, DsC

  Scientisic research institute of cardiology and internal diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 4, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

KA (1)