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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metabolic Syndrome
Interventions Drug: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin
Dietary Supplement: "Analimentary detoxication"
Enrollment 351
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Healthy People
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Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
Period Title: Overall Study
Started 70 269 66
Completed 65 222 64
Not Completed 5 47 2
Reason Not Completed
Moved out of area             1             8             0
Refused treatment             4             39             2
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Healthy People Total
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Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people Total of all reporting groups
Overall Number of Baseline Participants 65 222 64 351
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 65 participants 222 participants 64 participants 351 participants
46.5  (13.6) 47.4  (12.8) 47.7  (12.3) 47.3  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 222 participants 64 participants 351 participants
Female
34
  52.3%
116
  52.3%
34
  53.1%
184
  52.4%
Male
31
  47.7%
106
  47.7%
30
  46.9%
167
  47.6%
1.Primary Outcome
Title Blood Glucose Level
Hide Description Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Weight Loss Healthy People
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Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
Overall Number of Participants Analyzed 65 222 64
Mean (Standard Error)
Unit of Measure: mmole/L
Fasting blood glucose level 6.05  (0.46) 6.43  (0.36) 4.58  (0.18)
Two-hour postprandial glucose 14.5  (0.28) 14.6  (0.28) 5.3  (0.14)
2.Primary Outcome
Title Systolic/ Diastolic Blood Pressures (mm Hg)
Hide Description Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Weight Loss Healthy People
Hide Arm/Group Description:

Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
Overall Number of Participants Analyzed 65 222 64
Mean (Standard Error)
Unit of Measure: mm Hg
Systolic Blood Pressures 151.2  (1.1) 152.1  (1.1) 121.1  (0.7)
Diastolic Blood Pressures 94.1  (0.7) 96.9  (0.8) 79.9  (0.5)
3.Secondary Outcome
Title Lipid Profile
Hide Description Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Weight Loss Healthy People
Hide Arm/Group Description:

Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
Overall Number of Participants Analyzed 65 222 64
Mean (Standard Error)
Unit of Measure: mmole/L
Cholesterol 5.22  (0.18) 5.35  (0.17) 4.9  (0.14)
High-density Lipoproteids 0.76  (0.007) 0.75  (0.004) 1.22  (0.007)
Triglycerides 2.1  (0.18) 2.2  (0.12) 1.4  (0.09)
4.Secondary Outcome
Title Immunoassay Hormones in Blood
Hide Description Immunoassay Insulin in the blood (in nU/L) was investigated
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Healthy People
Hide Arm/Group Description:

Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
Overall Number of Participants Analyzed 65 222 64
Mean (Standard Error)
Unit of Measure: nU/L
22.9  (1.1) 23.2  (1.0) 6.5  (0.3)
5.Secondary Outcome
Title Immunoassay Cortisole in Blood
Hide Description Immunoassay Cortisole in the blood (nmole/L) was measured
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Healthy People
Hide Arm/Group Description:

Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
Overall Number of Participants Analyzed 65 222 64
Mean (Standard Error)
Unit of Measure: nmol/L
743.8  (6.9) 751.2  (6.7) 445.3  (5.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Patient Group "Analimentary Detoxication" Healthy People
Hide Arm/Group Description

Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy

Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day

Dietary Supplement - Vegetable and salt diet. Weight loss program "Analimentary detoxication"

"Analimentary detoxication": Vegetable and salt diet

64 healthy people
All-Cause Mortality
Conventional Patient Group "Analimentary Detoxication" Healthy People
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Patient Group "Analimentary Detoxication" Healthy People
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/65 (44.62%)      26/222 (11.71%)      0/64 (0.00%)    
Gastrointestinal disorders       
Indigestions  [1]  29/65 (44.62%)  78 26/222 (11.71%)  26 0/64 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
diarrhea, itching, gastritis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conventional Patient Group "Analimentary Detoxication" Healthy People
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/65 (75.38%)      62/222 (27.93%)      0/64 (0.00%)    
Cardiac disorders       
hypertension   42/65 (64.62%)  164 26/222 (11.71%)  52 0/64 (0.00%)  0
General disorders       
hypertermia   40/65 (61.54%)  160 62/222 (27.93%)  124 0/64 (0.00%)  0
Indicates events were collected by systematic assessment
We acknowledge the randomized clinical trial have not a large sample size
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kuat Oshakbayev
Organization: Republican Scientific Center for Emergency care at Nazarbayev University
Phone: +77013999141
Responsible Party: Kuat Oshakbayev, Nazarbayev University Medical Center
ClinicalTrials.gov Identifier: NCT02503865     History of Changes
Other Study ID Numbers: 0103RK00112
First Submitted: April 10, 2015
First Posted: July 21, 2015
Results First Submitted: July 21, 2015
Results First Posted: November 3, 2015
Last Update Posted: November 30, 2015