Clinical trial NCT00923260: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Morbid Obesity
Keywords: Omentectomy
metabolic syndrome
acute phase reactants
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Components of Metabolic Syndrome (Body Mass Index)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Body Mass Index)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Body Mass Index)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Body Mass Index)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Body Mass Index)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Systolic Blood Pressure)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Systolic Blood Pressure)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Systolic Blood Pressure)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Systolic Blood Pressure)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Systolic Blood Pressure)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Diastolic Blood Pressure)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Diastolic Blood Pressure)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Diastolic Blood Pressure)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Diastolic Blood Pressure)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Diastolic Blood Pressure)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Glucose)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Glucose)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Glucose)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Glucose)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Glucose)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Insulin)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Insulin)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Insulin)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Insulin)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Total Cholesterol)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Total Cholesterol)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Total Cholesterol)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Total Cholesterol)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Total Cholesterol)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Triglycerides)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Triglycerides)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Triglycerides)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Triglycerides)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Triglycerides)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (Low-Density Lipoproteins)
timeFrame: Basal
measure: Components of Metabolic Syndrome (Low-Density Lipoproteins)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (Low-Density Lipoproteins)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (Low-Density Lipoproteins)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (Low-Density Lipoproteins)
timeFrame: 1 year
measure: Components of Metabolic Syndrome (High-Density Lipoproteins)
timeFrame: Basal
measure: Components of Metabolic Syndrome (High-Density Lipoproteins)
timeFrame: 1 month
measure: Components of Metabolic Syndrome (High-Density Lipoproteins)
timeFrame: 3 months
measure: Components of Metabolic Syndrome (High-Density Lipoproteins)
timeFrame: 6 months
measure: Components of Metabolic Syndrome (High-Density Lipoproteins)
timeFrame: 1 year
Secondary outcomes:
measure: Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
timeFrame: Basal
measure: Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
timeFrame: 3 months
measure: Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
timeFrame: 6 months
measure: Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
timeFrame: 1 year
measure: Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
timeFrame: Basal
measure: Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
timeFrame: 3 months
measure: Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
timeFrame: 6 months
measure: Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)
timeFrame: 1 year
measure: Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
timeFrame: Basal
measure: Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
timeFrame: 3 months
measure: Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
timeFrame: 6 months
measure: Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)
timeFrame: 1 year
measure: Acute Phase Reactants and Inflammatory Mediators (Leptin)
timeFrame: Basal
measure: Acute Phase Reactants and Inflammatory Mediators (Leptin)
timeFrame: 3 months
measure: Acute Phase Reactants and Inflammatory Mediators (Leptin)
timeFrame: 6 months
measure: Acute Phase Reactants and Inflammatory Mediators (Leptin)
timeFrame: 1 year
measure: Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
timeFrame: Basal
measure: Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
timeFrame: 3 months
measure: Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
timeFrame: 6 months
measure: Acute Phase Reactants and Inflammatory Mediators (Adiponectin)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Miguel F Herrrera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.