| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | The Role of the Omentum in the Treatment of Morbid Obesity | ||||
| Official Title † | The Role of the Omentum in the Treatment of Morbid Obesity | ||||
| 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 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. |
||||
| Detailed Description | 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. |
||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | change in insulin sensitivity [ Time Frame: 2 year ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Condition † | Obesity | ||||
| Intervention † | Procedure: RYGB with omentectomy Procedure: omentectomy Procedure: RYGB without omentectomy |
||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 135 | ||||
| Start Date † | January 2005 | ||||
| Completion Date | June 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
|
||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00212160 | ||||
| Organization ID | IRB #040572 | ||||
| Secondary IDs †† | 3 RO1 DK 070860-01S1 | ||||
| Study Sponsor † | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators †† | |||||
| Investigators † |
|
||||
| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Verification Date | December 2008 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | December 1, 2008 | ||||
|
