Omentectomy and Metabolic Syndrome

November 24, 2009 updated by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Components of Metabolic Syndrome (Body Mass Index)
Time Frame: Basal
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)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Basal
Components of Metabolic Syndrome (Glucose)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Basal
Components of Metabolic Syndrome (Insulin)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
Basal
Components of Metabolic Syndrome (Triglycerides)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 1 month
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)
Time Frame: Basal
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
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)
Time Frame: Basal
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 1 year
Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Miguel F Herrrera, MD, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCMNSZ-1486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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