The Role of the Omentum in the Treatment of Morbid Obesity
This trial is active, not recruiting.
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||January 2005|
|End date||December 2016|
|Trial size||66 participants|
|Trial identifier||NCT00212160, 3 RO1 DK 070860-01S1, IRB #040572, NCT00247598, R01DK070860|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
change in insulin sensitivity
time frame: 5 year
time frame: 5 years
Male or female participants from 18 years up to 65 years old.
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
|Official title||The Role of the Omentum in the Treatment of Morbid Obesity|
|Principal investigator||Naji N Abumrad, MD|
|Description||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.|
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