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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00212160 |
Purpose
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 weigh 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.
| Condition | Intervention |
|---|---|
|
Obesity |
Procedure: RYGB with omentectomy Procedure: omentectomy Procedure: RYGB without omentectomy |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Role of the Omentum in the Treatment of Morbid Obesity |
| Estimated Enrollment: | 135 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
RYGB with omentectomy
|
Procedure: RYGB with omentectomy
RYGB with omentectomy
Procedure: omentectomy
RYGB with omentectomy
|
|
2: Active Comparator
RYGB without omentectomy
|
Procedure: RYGB without omentectomy
RYGB without omentectomy
|
The purpose of this research is to tease out the mechanisms related to metabolic improvements 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pamela A Marks, MS, RD | 615-343-8389 | pamela.a.marks@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Naji N Abumrad, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Naji Abumrad, MD ) |
| Study ID Numbers: | IRB #040572, 3 RO1 DK 070860-01S1 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00212160 History of Changes |
| Health Authority: | United States: Federal Government |
|
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Obesity, Morbid |
