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Completed

NCT Number: NCT02503865

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

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

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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

25 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Republican Scientific Center for Emergency Medicine

Astana, 010000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin

Drug

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

"Analimentary detoxication"

Dietary Supplement

Vegetable and salt diet

Other names: Experimental Patient group

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. Immunoassay Hormones in Blood

    Time frame: up to 12 weeks

    Immunoassay Insulin in the blood (in nU/L) was investigated

  3. Immunoassay Cortisole in Blood

    Time frame: up to 12 weeks

    Immunoassay Cortisole in the blood (nmole/L) was measured

Sponsors and collaborators

Lead sponsor

Nazarbayev University

Other

Collaborators

  • Institute Of Cardiology & Internal Diseases, Kazakhstan

Registry information

Official study title

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

Acronym: DRWMNTMS

Important dates

Study start
2003
Primary completion
2008
Study completion
2014
First posted
Jul 21, 2015
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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