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

Phase 1

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: "Analimentary detoxication"; Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

• Registration Number: NCT02503865
• Lead Sponsor: Nazarbayev University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2008-12
• Study Completion: 2014-12
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Results First Submitted: 2015-07-21
• Results First Submitted QC: 2015-10-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Results First Posted: 2015-11-03
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Analimentary detoxication" Weight loss	"Analimentary detoxication"	Vegetables and salt diet
Conventional Patient group	Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin	Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Republican Scientific Center for Emergency Medicine; 🇰🇿 Astana, Kazakhstan