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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"

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Conventional Patient Group

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

"Analimentary Detoxication"

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

"Analimentary detoxication": Vegetable and salt diet

Healthy People 64 healthy people

Participant Flow:   Overall Study
    Conventional Patient Group   "Analimentary Detoxication"   Healthy People
STARTED   70   269   66 
COMPLETED   65   222   64 
NOT COMPLETED   5   47   2 
Moved out of area                1                8                0 
Refused treatment                4                39                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Conventional Patient Group

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

"Analimentary Detoxication"

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

"Analimentary detoxication": Vegetable and salt diet

Healthy People 64 healthy people
Total Total of all reporting groups

Baseline Measures
   Conventional Patient Group   "Analimentary Detoxication"   Healthy People   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   222   64   351 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
       
Age   46.5  (13.6)   47.4  (12.8)   47.7  (12.3)   47.3  (12.9) 
Gender 
[Units: Participants]
       
Female   34   116   34   184 
Male   31   106   30   167 


  Outcome Measures

1.  Primary:   Blood Glucose Level   [ Time Frame: up to 12 weeks ]

2.  Primary:   Systolic/ Diastolic Blood Pressures (mm Hg)   [ Time Frame: up to 12 weeks ]

3.  Secondary:   Lipid Profile   [ Time Frame: up to 12 weeks ]

4.  Secondary:   Immunoassay Hormones in Blood   [ Time Frame: up to 12 weeks ]

5.  Secondary:   Immunoassay Cortisole in Blood   [ Time Frame: up to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We acknowledge the randomized clinical trial have not a large sample size


  More Information

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
e-mail: okp.kuat@mail.ru


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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