NCT00923260

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

June 18, 2009

Completed
Last Updated

December 7, 2009

Status Verified

November 1, 2009

Enrollment Period

1.8 years

First QC Date

January 28, 2009

Results QC Date

January 28, 2009

Last Update Submit

November 24, 2009

Conditions

Metabolic SyndromeMorbid Obesity

Keywords

Omentectomymetabolic syndromeacute phase reactants

Outcome Measures

Primary Outcomes (44)

  • 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 Outcomes (20)

  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    Basal

  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    3 months

  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    6 months

  • Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)

    1 year

  • Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)

    Basal

  • +15 more secondary outcomes

Study Arms (2)

Roux-en-Y Gastric Bypass/Omentectomy

EXPERIMENTAL

Laparoscopic Roux-en-Y Gastric Bypass with omentectomy

Procedure: Laparoscopic Roux-en-Y Gastric BypassProcedure: Omentectomy

Roux-en-Y Gastric Bypass alone

ACTIVE COMPARATOR
Procedure: Laparoscopic Roux-en-Y Gastric Bypass

Interventions

Laparoscopic Roux-en-Y Gastric BypassPROCEDURE

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.

Roux-en-Y Gastric Bypass aloneRoux-en-Y Gastric Bypass/Omentectomy
OmentectomyPROCEDURE

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.

Roux-en-Y Gastric Bypass/Omentectomy

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 35 Kg/m2
  • Metabolic syndrome diagnosed

You may not qualify if:

  • Type 1 diabetes
  • Uncontrolled type 2 diabetes
  • Cirrhosis or active hepatitis
  • Pregnancy
  • Recent MI or stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20587720DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesity, Morbid

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

An important limitation of our study is the small number of studied patients.

Results Point of Contact

Title
Dr. Miguel F Herrera
Organization
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
miguelfherrera@gmail.com
(+52) 55 54870208

Study Officials

  • Miguel F Herrrera, MD, PhD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2009

First Posted

June 18, 2009

Study Start

December 1, 2005

Primary Completion

October 1, 2007

Study Completion

July 1, 2008

Last Updated

December 7, 2009

Results First Posted

June 18, 2009

Record last verified: 2009-11