Omentectomy and Metabolic Syndrome

Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Morbid Obesity
• Intervention / Treatment: Procedure: Laparoscopic Roux-en-Y Gastric Bypass; Procedure: Omentectomy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Roux-en-Y Gastric Bypass/Omentectomy; Laparoscopic Roux-en-Y Gastric Bypass with omentectomy	Procedure: Laparoscopic Roux-en-Y Gastric Bypass; 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.; Procedure: Omentectomy; 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.
Active Comparator: Roux-en-Y Gastric Bypass alone	Procedure: Laparoscopic Roux-en-Y Gastric Bypass; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Basal
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.	1 month
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.	3 months
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.	6 months
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.	1 year
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.	Basal
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.	1 month
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.	3 months
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.	6 months
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.	1 year
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.	Basal
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.	1 month
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.	3 months
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.	6 months
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.	1 year
Components of Metabolic Syndrome (Glucose)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	Basal
Components of Metabolic Syndrome (Glucose)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 month
Components of Metabolic Syndrome (Glucose)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	3 months
Components of Metabolic Syndrome (Glucose)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	6 months
Components of Metabolic Syndrome (Glucose)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 year
Components of Metabolic Syndrome (Insulin)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	Basal
Components of Metabolic Syndrome (Insulin)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	3 months
Components of Metabolic Syndrome (Insulin)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	6 months
Components of Metabolic Syndrome (Insulin)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 year
Components of Metabolic Syndrome (Total Cholesterol)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	Basal
Components of Metabolic Syndrome (Total Cholesterol)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 month
Components of Metabolic Syndrome (Total Cholesterol)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	3 months
Components of Metabolic Syndrome (Total Cholesterol)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	6 months
Components of Metabolic Syndrome (Total Cholesterol)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 year
Components of Metabolic Syndrome (Triglycerides)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	Basal
Components of Metabolic Syndrome (Triglycerides)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 month
Components of Metabolic Syndrome (Triglycerides)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	3 months
Components of Metabolic Syndrome (Triglycerides)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	6 months
Components of Metabolic Syndrome (Triglycerides)	Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.	1 year
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.	Basal
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.	1 month
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.	3 months
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.	6 months
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.	1 year
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.	Basal
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.	1 month
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.	3 months
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.	6 months
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Basal
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.	3 months
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.	6 months
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.	1 year
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	Basal
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.	3 months
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.	6 months
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	1 year
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.	Basal
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.	3 months
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	6 months
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.	1 year
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.	Basal
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.	3 months
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.	6 months
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.	1 year
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.	Basal
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.	3 months
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.	6 months
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.	1 year

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: Miguel F Herrrera, MD, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: January 28, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): June 18, 2009

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: November 24, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: metabolic syndrome; Omentectomy; acute phase reactants
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Syndrome; Metabolic Syndrome; Obesity, Morbid
• Other Study ID Numbers: INCMNSZ-1486