Omentectomy and Metabolic Syndrome

Not Applicable

Completed

• Conditions: Morbid Obesity; Metabolic Syndrome
• Interventions: Procedure: Laparoscopic Roux-en-Y Gastric Bypass; Procedure: Omentectomy

• Registration Number: NCT00923260
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-10
• Study Completion: 2008-07
• Study First Submitted: 2009-01-28
• Results First Submitted: 2009-01-28
• Study First Submitted QC: 2009-04-30
• Results First Submitted QC: 2009-04-30
• Study First Posted: 2009-06-18
• Results First Posted: 2009-06-18
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roux-en-Y Gastric Bypass/Omentectomy	Omentectomy	Laparoscopic Roux-en-Y Gastric Bypass with omentectomy
Roux-en-Y Gastric Bypass/Omentectomy	Laparoscopic Roux-en-Y Gastric Bypass	Laparoscopic Roux-en-Y Gastric Bypass with omentectomy
Roux-en-Y Gastric Bypass alone	Laparoscopic Roux-en-Y Gastric Bypass	-

Primary Outcome Measures

Name	Time	Method
Components of Metabolic Syndrome (Body Mass Index)	1 year	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)	1 year	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Triglycerides)	1 year	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)	1 year	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)	1 year	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Total Cholesterol)	1 year	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Glucose)	1 year	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Components of Metabolic Syndrome (Insulin)	1 year	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)	1 year	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.

Secondary Outcome Measures

Name	Time	Method
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)	1 year	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)	1 year	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)	1 year	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)	1 year	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)	1 year	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.