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

Nazarbayev University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: "Analimentary detoxication"; Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02503865

0103RK00112

Details and patient eligibility

About

Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis

Full description

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.

Enrollment: 351 patients

Sex: All

Ages: 25 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 3 patient groups

Conventional Patient group

Active Comparator group

Description:

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Treatment:

Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

"Analimentary detoxication" Weight loss

Experimental group

Description:

Vegetables and salt diet

Treatment:

Dietary Supplement: "Analimentary detoxication"

Healthy people

No Intervention group

Description:

64 healthy people