The Role of the Omentum in the Treatment of Morbid Obesity

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: omentectomy

• Registration Number: NCT00212160
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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Exclusion Criteria

• use of anticoagulants, steroids, therapeutic niacin
• previous bariatric surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGB with omentectomy	omentectomy	Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.

Primary Outcome Measures

Name	Time	Method
change in insulin sensitivity	5 year

Secondary Outcome Measures

Name	Time	Method
Weight loss	5 years

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States