The Role of the Omentum in the Treatment of Morbid Obesity
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||The Role of the Omentum in the Treatment of Morbid Obesity|
- change in insulin sensitivity [ Time Frame: 5 year ] [ Designated as safety issue: No ]
- Weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: RYGB with omentectomy
Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.
RYGB with 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212160
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Naji N Abumrad, MD||Vanderbilt University Medical Center|