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

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ClinicalTrials.gov Identifier: NCT02503865
Recruitment Status : Completed
First Posted : July 21, 2015
Results First Posted : November 3, 2015
Last Update Posted : November 30, 2015
Sponsor:
Collaborator:
Institute Of Cardiology & Internal Diseases, Kazakhstan
Information provided by (Responsible Party):
Kuat Oshakbayev, Nazarbayev University Medical Center

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin Dietary Supplement: "Analimentary detoxication" Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
Study Start Date : January 2003
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: Conventional Patient group

Experimental: "Analimentary detoxication" Weight loss
Vegetables and salt diet
Dietary Supplement: "Analimentary detoxication"
Vegetable and salt diet
Other Name: Experimental Patient group

No Intervention: Healthy people
64 healthy people



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503865


Locations
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Kazakhstan
Republican Scientific Center for Emergency Medicine
Astana, Kazakhstan, 010000
Sponsors and Collaborators
Nazarbayev University Medical Center
Institute Of Cardiology & Internal Diseases, Kazakhstan
Investigators
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Study Director: Tabynbayev Nariman, Professor Nazarbayev University Medical Center

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kuat Oshakbayev, Primary investigator, Nazarbayev University Medical Center
ClinicalTrials.gov Identifier: NCT02503865     History of Changes
Other Study ID Numbers: 0103RK00112
First Posted: July 21, 2015    Key Record Dates
Results First Posted: November 3, 2015
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Kuat Oshakbayev, Nazarbayev University Medical Center:
Metabolic syndrome
Diabetes mellitus,
Hypertension
Overweight
analimentary detoxication

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin
Orlistat
Diltiazem
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Obesity Agents