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
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin Dietary Supplement: "Analimentary detoxication"||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- 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
- Immunoassay Hormones in Blood [ Time Frame: up to 12 weeks ]Immunoassay Insulin in the blood (in nU/L) was investigated
- Immunoassay Cortisole in Blood [ Time Frame: up to 12 weeks ]Immunoassay Cortisole in the blood (nmole/L) was measured
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
|Republican Scientific Center for Emergency Medicine|
|Astana, Kazakhstan, 010000|
|Study Director:||Tabynbayev Nariman, Professor||Nazarbayev University Medical Center|