Omentectomy and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923260
• Other study ID #: INCMNSZ-1486
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: November 24, 2009
• Start date: December 2005
• Est. completion date: July 2008

Study information

• Verified date: November 2009
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Morbid Obesity
• Obesity, Morbid
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Components of Metabolic Syndrome (Body Mass Index)		Basal	Yes
Primary	Components of Metabolic Syndrome (Body Mass Index)		1 month	Yes
Primary	Components of Metabolic Syndrome (Body Mass Index)		3 months	Yes
Primary	Components of Metabolic Syndrome (Body Mass Index)		6 months	Yes
Primary	Components of Metabolic Syndrome (Body Mass Index)		1 year	Yes
Primary	Components of Metabolic Syndrome (Systolic Blood Pressure)		Basal	Yes
Primary	Components of Metabolic Syndrome (Systolic Blood Pressure)		1 month	Yes
Primary	Components of Metabolic Syndrome (Systolic Blood Pressure)		3 months	Yes
Primary	Components of Metabolic Syndrome (Systolic Blood Pressure)		6 months	Yes
Primary	Components of Metabolic Syndrome (Systolic Blood Pressure)		1 year	Yes
Primary	Components of Metabolic Syndrome (Diastolic Blood Pressure)		Basal	Yes
Primary	Components of Metabolic Syndrome (Diastolic Blood Pressure)		1 month	Yes
Primary	Components of Metabolic Syndrome (Diastolic Blood Pressure)		3 months	Yes
Primary	Components of Metabolic Syndrome (Diastolic Blood Pressure)		6 months	Yes
Primary	Components of Metabolic Syndrome (Diastolic Blood Pressure)		1 year	Yes
Primary	Components of Metabolic Syndrome (Glucose)		Basal	Yes
Primary	Components of Metabolic Syndrome (Glucose)		1 month	Yes
Primary	Components of Metabolic Syndrome (Glucose)		3 months	Yes
Primary	Components of Metabolic Syndrome (Glucose)		6 months	Yes
Primary	Components of Metabolic Syndrome (Glucose)		1 year	Yes
Primary	Components of Metabolic Syndrome (Insulin)		Basal	Yes
Primary	Components of Metabolic Syndrome (Insulin)		3 months	Yes
Primary	Components of Metabolic Syndrome (Insulin)		6 months	Yes
Primary	Components of Metabolic Syndrome (Insulin)		1 year	Yes
Primary	Components of Metabolic Syndrome (Total Cholesterol)		Basal	Yes
Primary	Components of Metabolic Syndrome (Total Cholesterol)		1 month	Yes
Primary	Components of Metabolic Syndrome (Total Cholesterol)		3 months	Yes
Primary	Components of Metabolic Syndrome (Total Cholesterol)		6 months	Yes
Primary	Components of Metabolic Syndrome (Total Cholesterol)		1 year	Yes
Primary	Components of Metabolic Syndrome (Triglycerides)		Basal	Yes
Primary	Components of Metabolic Syndrome (Triglycerides)		1 month	Yes
Primary	Components of Metabolic Syndrome (Triglycerides)		3 months	Yes
Primary	Components of Metabolic Syndrome (Triglycerides)		6 months	Yes
Primary	Components of Metabolic Syndrome (Triglycerides)		1 year	Yes
Primary	Components of Metabolic Syndrome (Low-Density Lipoproteins)		Basal	Yes
Primary	Components of Metabolic Syndrome (Low-Density Lipoproteins)		1 month	Yes
Primary	Components of Metabolic Syndrome (Low-Density Lipoproteins)		3 months	Yes
Primary	Components of Metabolic Syndrome (Low-Density Lipoproteins)		6 months	Yes
Primary	Components of Metabolic Syndrome (Low-Density Lipoproteins)		1 year	Yes
Primary	Components of Metabolic Syndrome (High-Density Lipoproteins)		Basal	Yes
Primary	Components of Metabolic Syndrome (High-Density Lipoproteins)		1 month	Yes
Primary	Components of Metabolic Syndrome (High-Density Lipoproteins)		3 months	Yes
Primary	Components of Metabolic Syndrome (High-Density Lipoproteins)		6 months	Yes
Primary	Components of Metabolic Syndrome (High-Density Lipoproteins)		1 year	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)		Basal	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)		3 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)		6 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)		1 year	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)		Basal	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)		3 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)		6 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)		1 year	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)		Basal	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)		3 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)		6 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)		1 year	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Leptin)		Basal	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Leptin)		3 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Leptin)		6 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Leptin)		1 year	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Adiponectin)		Basal	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Adiponectin)		3 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Adiponectin)		6 months	Yes
Secondary	Acute Phase Reactants and Inflammatory Mediators (Adiponectin)		1 year	Yes