The Role of the Omentum in the Treatment of Morbid Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00212160
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013

September 13, 2005
June 17, 2013
January 2005
October 2011   (final data collection date for primary outcome measure)
change in insulin sensitivity [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Change in insulin sensitivity
  • Change in resting energy expenditure
  • Change in intramyocellular fat
  • Change in endogenous glucose production
Complete list of historical versions of study NCT00212160 on ClinicalTrials.gov Archive Site
Weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Weight loss
Not Provided
Not Provided
 
The Role of the Omentum in the Treatment of Morbid Obesity
The Role of the Omentum in the Treatment of Morbid Obesity

The purpose of this research is to determine some of the reasons that blood sugar and insulin levels improve after bariatric surgery but before weight loss begins, as well as why people respond differently to weight loss surgery. It will also examine whether removing the fat around the stomach and large intestine (the omentum) will improve weight loss. Finally, it will see why there are differences between Whites and African Americans who have weight loss surgery.

The purpose of this research is to tease out the mechanisms related to changes in insulin sensitivity, metabolism, hormones, and body composition following bariatric surgery. Because preliminary data indicate differing responses to this surgery, both Caucasian and African American adults, scheduled for RYGB, are being recruited to participate. It is believed that the omentum contributes to hepatic insulin resistance, both because of the increased delivery of NEFAs via the portal vein, and the increased production of cytokines. Because of this, it is postulated that removing the omentum as part of bariatric surgery will speed up the reversal of insulin resistance and diminish racial differences in response to the surgery.

Data are derived from tissue and blood samples obtained operatively (from individuals having bariatric surgery and other abdominal operations), as well as during hyperinsulinemic-euglycemic clamps, from indirect calorimetry, DEXA, Health-related Quality of Life surveys, and 24-hour urine samples. There were 66 participants randomized to omentectomy/no omentectomy. A post hoc data power analysis determined that this number of subjects is sufficient for data analysis.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Obesity
Procedure: omentectomy
RYGB with omentectomy
  • Experimental: RYGB with omentectomy
    Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.
    Intervention: Procedure: omentectomy
  • No Intervention: RYGB without omentectomy
    Subjects undergoing RYGB will be randomized to NOT have the greater omentum removed at the time of surgery.
  • No Intervention: Normal body weight
    Healthy normal weight subjects studied via hyperinsulinemic-euglycemic clamp to obtain reference values for insulin sensitivity and other metabolic parameters.
  • No Intervention: Tissue samples
    Tissue samples (omental fat, subcutaneous fat, muscle,and blood)are obtained from subjects of varying weights during abdominal surgery in order to compare various parameters, including inflammation, oxidative stress, and gene expression, among tissues across weight classes.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
December 2013
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 40
  • BMI > 35 with co-morbidities
  • normal creatinine/liver labs
  • insurance approval for RYGB or resources to self-pay
  • proximity to Nashville, TN

Exclusion Criteria:

  • use of anticoagulants, steroids, therapeutic niacin
  • previous bariatric surgery
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00212160
IRB #040572, R01DK070860, 3 RO1 DK 070860-01S1
Yes
Naji Abumrad, Vanderbilt University
Vanderbilt University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Naji N Abumrad, MD Vanderbilt University
Vanderbilt University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP