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

November 2, 2015 updated by: Kuat Oshakbayev, Nazarbayev University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Republican Scientific Center for Emergency Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Patient group
Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin
Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin
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
Other Names:
  • Conventional Patient group
Experimental: "Analimentary detoxication" Weight loss
Vegetables and salt diet
Dietary supplement: "Analimentary detoxication"
Vegetable and salt diet
Other Names:
  • Experimental Patient group
No Intervention: Healthy people
64 healthy people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose Level
Time Frame: up to 12 weeks
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)
Time Frame: up to 12 weeks
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
Time Frame: 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
up to 12 weeks
Immunoassay Hormones in Blood
Time Frame: up to 12 weeks
Immunoassay Insulin in the blood (in nU/L) was investigated
up to 12 weeks
Immunoassay Cortisole in Blood
Time Frame: up to 12 weeks
Immunoassay Cortisole in the blood (nmole/L) was measured
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazarbayev University

Collaborators

Institute Of Cardiology & Internal Diseases, Kazakhstan

Investigators

  • Study Director: Tabynbayev Nariman, Professor, Nazarbayev University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0103RK00112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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