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Omentectomy and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Roux-en-Y Gastric Bypass
Omentectomy
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Omentectomy, metabolic syndrome, acute phase reactants

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 35 Kg/m2
  • Metabolic syndrome diagnosed

Exclusion Criteria:

  • Type 1 diabetes
  • Uncontrolled type 2 diabetes
  • Cirrhosis or active hepatitis
  • Pregnancy
  • Recent MI or stroke

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Roux-en-Y Gastric Bypass/Omentectomy

    Roux-en-Y Gastric Bypass alone

    Arm Description

    Laparoscopic Roux-en-Y Gastric Bypass with omentectomy

    Outcomes

    Primary Outcome Measures

    Components of Metabolic Syndrome (Body Mass Index)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Body Mass Index)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Body Mass Index)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Body Mass Index)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Body Mass Index)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Glucose)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Glucose)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Glucose)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Glucose)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Glucose)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Insulin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Insulin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Insulin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Insulin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Total Cholesterol)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Total Cholesterol)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Total Cholesterol)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Total Cholesterol)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Total Cholesterol)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Triglycerides)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Triglycerides)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Triglycerides)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Triglycerides)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Triglycerides)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

    Secondary Outcome Measures

    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

    Full Information

    First Posted
    January 28, 2009
    Last Updated
    November 24, 2009
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00923260
    Brief Title
    Omentectomy and Metabolic Syndrome
    Official Title
    Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the present study was to evaluate the additional effect of sudden visceral fat reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.
    Detailed Description
    Although weight loss controls Metabolic Syndrome and reduces the level of inflammatory markers in patients with Morbid Obesity, patients may enjoy the benefit achieving metabolic control before significant weight loss occurs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Morbid Obesity
    Keywords
    Omentectomy, metabolic syndrome, acute phase reactants

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Roux-en-Y Gastric Bypass/Omentectomy
    Arm Type
    Experimental
    Arm Description
    Laparoscopic Roux-en-Y Gastric Bypass with omentectomy
    Arm Title
    Roux-en-Y Gastric Bypass alone
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Roux-en-Y Gastric Bypass
    Intervention Description
    Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Omentectomy
    Intervention Description
    After laparoscopic gastric bypass, the greater omentum was divided in the middle from the free edge to the colonic margin using ultrasonic energy. Attachments between the omentum and the transverse colon were dissected. The omentum was detached from the stomach transecting the vessels between the right gastroepiploic vessels and the greater curvature of the stomach. Once the omentum was freed from the stomach, the duodenum and the lower pole of the spleen, it was extracted from the abdominal cavity in a sterile plastic bag.
    Primary Outcome Measure Information:
    Title
    Components of Metabolic Syndrome (Body Mass Index)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Body Mass Index)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Body Mass Index)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Body Mass Index)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Body Mass Index)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Systolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Diastolic Blood Pressure)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Glucose)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Glucose)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Glucose)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Glucose)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Glucose)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Insulin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Insulin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Insulin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Insulin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Total Cholesterol)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Total Cholesterol)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Total Cholesterol)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Total Cholesterol)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Total Cholesterol)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Triglycerides)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Triglycerides)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Triglycerides)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Triglycerides)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Triglycerides)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (Low-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 month
    Title
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Components of Metabolic Syndrome (High-Density Lipoproteins)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Time Frame
    Basal
    Title
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Time Frame
    Basal
    Title
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Time Frame
    1 year
    Title
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement
    Time Frame
    6 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Leptin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year
    Title
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    Basal
    Title
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    3 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    6 months
    Title
    Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
    Description
    Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI > 35 Kg/m2 Metabolic syndrome diagnosed Exclusion Criteria: Type 1 diabetes Uncontrolled type 2 diabetes Cirrhosis or active hepatitis Pregnancy Recent MI or stroke
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miguel F Herrrera, MD, PhD
    Organizational Affiliation
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20587720
    Citation
    Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.
    Results Reference
    derived

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    Omentectomy and Metabolic Syndrome

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