Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome

Study Overview
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Brief Summary
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Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis

Detailed Description
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Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS) development based on elaboration of the new methods of clinical diagnostics of МS components and highly effective МS clinical management in comparative studying of clinical, laboratory and cost effectiveness. Participants and methods: This clinical study included 351 adults (184 female) in the Scientific research institute of cardiology and internal diseases (Almaty, the Republic of Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.

Official Title
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Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin
* Dietary Supplement: Analimentary detoxication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written consent form age> 25 years skinfold thickness > 0,7 cm BP> 130/85 mm Hg or a patient on antihypertensive medications fasting blood glucose > 6.1 mmole/L, or 2-hour postprandial glucose level > 11.1 mmole/L / or a patient with type 2 diabetes blood cholesterol > 5.6 mmole/L possibility of treatment > 6 months follow-up > 1 year Exclusion Criteria: complete immobilization of a patient (paresis /paralysis) patients with severe concomitant diseases of the kidneys and (or) of the liver early post-operative condition mental illness pregnancy persons who are in prison persons who are in military Armed Forces

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Patient group<br>Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin | Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin<br>* Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day<br>* Other names: Conventional Patient group;|
| Experimental: Analimentary detoxication Weight loss<br>Vegetables and salt diet | Dietary Supplement: Analimentary detoxication<br>* Vegetable and salt diet<br>* Other names: Experimental Patient group;|
| No Intervention: Healthy people<br>64 healthy people | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Level | Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured. | up to 12 weeks | 
| Systolic/ Diastolic Blood Pressures (mm Hg) | Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile | Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured | up to 12 weeks | 
| Immunoassay Hormones in Blood | Immunoassay Insulin in the blood (in nU/L) was investigated | up to 12 weeks | 
| Immunoassay Cortisole in Blood | Immunoassay Cortisole in the blood (nmole/L) was measured | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Diabetes mellitus,, Hypertension, Overweight, analimentary detoxication