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
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Morbid Obesity
Procedure: Laparoscopic Roux-en-Y Gastric Bypass
Procedure: Omentectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Omentectomy on Metabolic Syndrome, Acute Phase Reactants & Inflammatory Mediators in Patients Undergoing LRYGBP: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Components of Metabolic Syndrome (Body Mass Index) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Body Mass Index) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Body Mass Index) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Body Mass Index) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Body Mass Index) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Systolic Blood Pressure) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Systolic Blood Pressure) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Systolic Blood Pressure) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Systolic Blood Pressure) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Systolic Blood Pressure) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Diastolic Blood Pressure) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Diastolic Blood Pressure) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Diastolic Blood Pressure) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Diastolic Blood Pressure) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Diastolic Blood Pressure) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Glucose) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Glucose) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Glucose) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Glucose) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Glucose) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Insulin) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Insulin) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Insulin) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Insulin) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Total Cholesterol) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Total Cholesterol) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Total Cholesterol) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Total Cholesterol) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Total Cholesterol) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Triglycerides) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Triglycerides) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Triglycerides) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Triglycerides) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Triglycerides) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Low-Density Lipoproteins) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Low-Density Lipoproteins) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Low-Density Lipoproteins) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Low-Density Lipoproteins) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (Low-Density Lipoproteins) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (High-Density Lipoproteins) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (High-Density Lipoproteins) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (High-Density Lipoproteins) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (High-Density Lipoproteins) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Components of Metabolic Syndrome (High-Density Lipoproteins) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Leptin) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Leptin) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Leptin) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Leptin) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Adiponectin) [ Time Frame: Basal ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Adiponectin) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Adiponectin) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute Phase Reactants and Inflammatory Mediators (Adiponectin) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923260

Sponsors and Collaborators
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
  More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Omentectomy
metabolic syndrome
acute phase reactants

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014