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Omentectomy and Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00923260
First received: January 28, 2009
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
Results First Received: January 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metabolic Syndrome
Morbid Obesity
Interventions: Procedure: Laparoscopic Roux-en-Y Gastric Bypass
Procedure: Omentectomy

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Roux-en-Y Gastric Bypass/Omentectomy No text entered.
Roux-en-Y Gastric Bypass Alone No text entered.
Total Total of all reporting groups

Baseline Measures
    Roux-en-Y Gastric Bypass/Omentectomy     Roux-en-Y Gastric Bypass Alone     Total  
Number of Participants  
[units: participants]
 		  12     12     24  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  36.8  ± 12.9     39.8  ± 11.1     38.3  ± 11.9  
Gender  
[units: participants]
 		     
Female     9     11     20  
Male     3     1     4  
Region of Enrollment  
[units: participants]
 		     
Mexico     12     12     24  



  Outcome Measures
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1.  Primary:   Components of Metabolic Syndrome (Body Mass Index)   [ Time Frame: Basal ]
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2.  Primary:   Components of Metabolic Syndrome (Body Mass Index)   [ Time Frame: 1 month ]
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3.  Primary:   Components of Metabolic Syndrome (Body Mass Index)   [ Time Frame: 3 months ]
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4.  Primary:   Components of Metabolic Syndrome (Body Mass Index)   [ Time Frame: 6 months ]
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5.  Primary:   Components of Metabolic Syndrome (Body Mass Index)   [ Time Frame: 1 year ]
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6.  Primary:   Components of Metabolic Syndrome (Systolic Blood Pressure)   [ Time Frame: Basal ]
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7.  Primary:   Components of Metabolic Syndrome (Systolic Blood Pressure)   [ Time Frame: 1 month ]
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8.  Primary:   Components of Metabolic Syndrome (Systolic Blood Pressure)   [ Time Frame: 3 months ]
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9.  Primary:   Components of Metabolic Syndrome (Systolic Blood Pressure)   [ Time Frame: 6 months ]
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10.  Primary:   Components of Metabolic Syndrome (Systolic Blood Pressure)   [ Time Frame: 1 year ]
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11.  Primary:   Components of Metabolic Syndrome (Diastolic Blood Pressure)   [ Time Frame: Basal ]
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12.  Primary:   Components of Metabolic Syndrome (Diastolic Blood Pressure)   [ Time Frame: 1 month ]
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13.  Primary:   Components of Metabolic Syndrome (Diastolic Blood Pressure)   [ Time Frame: 3 months ]
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14.  Primary:   Components of Metabolic Syndrome (Diastolic Blood Pressure)   [ Time Frame: 6 months ]
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15.  Primary:   Components of Metabolic Syndrome (Diastolic Blood Pressure)   [ Time Frame: 1 year ]
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16.  Primary:   Components of Metabolic Syndrome (Glucose)   [ Time Frame: Basal ]
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17.  Primary:   Components of Metabolic Syndrome (Glucose)   [ Time Frame: 1 month ]
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18.  Primary:   Components of Metabolic Syndrome (Glucose)   [ Time Frame: 3 months ]
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19.  Primary:   Components of Metabolic Syndrome (Glucose)   [ Time Frame: 6 months ]
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20.  Primary:   Components of Metabolic Syndrome (Glucose)   [ Time Frame: 1 year ]
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21.  Primary:   Components of Metabolic Syndrome (Insulin)   [ Time Frame: Basal ]
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22.  Primary:   Components of Metabolic Syndrome (Insulin)   [ Time Frame: 3 months ]
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23.  Primary:   Components of Metabolic Syndrome (Insulin)   [ Time Frame: 6 months ]
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24.  Primary:   Components of Metabolic Syndrome (Insulin)   [ Time Frame: 1 year ]
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25.  Primary:   Components of Metabolic Syndrome (Total Cholesterol)   [ Time Frame: Basal ]
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26.  Primary:   Components of Metabolic Syndrome (Total Cholesterol)   [ Time Frame: 1 month ]
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27.  Primary:   Components of Metabolic Syndrome (Total Cholesterol)   [ Time Frame: 3 months ]
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28.  Primary:   Components of Metabolic Syndrome (Total Cholesterol)   [ Time Frame: 6 months ]
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29.  Primary:   Components of Metabolic Syndrome (Total Cholesterol)   [ Time Frame: 1 year ]
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30.  Primary:   Components of Metabolic Syndrome (Triglycerides)   [ Time Frame: Basal ]
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31.  Primary:   Components of Metabolic Syndrome (Triglycerides)   [ Time Frame: 1 month ]
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32.  Primary:   Components of Metabolic Syndrome (Triglycerides)   [ Time Frame: 3 months ]
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33.  Primary:   Components of Metabolic Syndrome (Triglycerides)   [ Time Frame: 6 months ]
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34.  Primary:   Components of Metabolic Syndrome (Triglycerides)   [ Time Frame: 1 year ]
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35.  Primary:   Components of Metabolic Syndrome (Low-Density Lipoproteins)   [ Time Frame: Basal ]
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36.  Primary:   Components of Metabolic Syndrome (Low-Density Lipoproteins)   [ Time Frame: 1 month ]
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37.  Primary:   Components of Metabolic Syndrome (Low-Density Lipoproteins)   [ Time Frame: 3 months ]
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38.  Primary:   Components of Metabolic Syndrome (Low-Density Lipoproteins)   [ Time Frame: 6 months ]
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39.  Primary:   Components of Metabolic Syndrome (Low-Density Lipoproteins)   [ Time Frame: 1 year ]
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40.  Primary:   Components of Metabolic Syndrome (High-Density Lipoproteins)   [ Time Frame: Basal ]
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41.  Primary:   Components of Metabolic Syndrome (High-Density Lipoproteins)   [ Time Frame: 1 month ]
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42.  Primary:   Components of Metabolic Syndrome (High-Density Lipoproteins)   [ Time Frame: 3 months ]
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43.  Primary:   Components of Metabolic Syndrome (High-Density Lipoproteins)   [ Time Frame: 6 months ]
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44.  Primary:   Components of Metabolic Syndrome (High-Density Lipoproteins)   [ Time Frame: 1 year ]
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45.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)   [ Time Frame: Basal ]
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46.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)   [ Time Frame: 3 months ]
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47.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)   [ Time Frame: 6 months ]
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48.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)   [ Time Frame: 1 year ]
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49.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)   [ Time Frame: Basal ]
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50.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)   [ Time Frame: 3 months ]
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51.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)   [ Time Frame: 6 months ]
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52.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)   [ Time Frame: 1 year ]
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53.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)   [ Time Frame: Basal ]
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54.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)   [ Time Frame: 3 months ]
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55.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)   [ Time Frame: 6 months ]
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56.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)   [ Time Frame: 1 year ]
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57.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Leptin)   [ Time Frame: Basal ]
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58.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Leptin)   [ Time Frame: 3 months ]
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59.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Leptin)   [ Time Frame: 6 months ]
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60.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Leptin)   [ Time Frame: 1 year ]
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61.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Adiponectin)   [ Time Frame: Basal ]
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62.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Adiponectin)   [ Time Frame: 3 months ]
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63.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Adiponectin)   [ Time Frame: 6 months ]
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64.  Secondary:   Acute Phase Reactants and Inflammatory Mediators (Adiponectin)   [ Time Frame: 1 year ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
An important limitation of our study is the small number of studied patients.  


Results Point of Contact:  
Name/Title: Dr. Miguel F Herrera
Organization: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
phone: (+52) 55 54870208
e-mail: miguelfherrera@gmail.com


No publications provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications automatically indexed to this study:


Responsible Party: Miguel Francisco Herrera, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00923260     History of Changes
Other Study ID Numbers: INCMNSZ-1486
Study First Received: January 28, 2009
Results First Received: January 28, 2009
Last Updated: November 24, 2009
Health Authority: Mexico: Ethics Committee