| September 13, 2005 |
| June 4, 2009 |
| January 2005 |
| June 2010 (final data collection date for primary outcome measure) |
| change in insulin sensitivity [ Time Frame: 2 year ] [ Designated as safety issue: No ] |
- Change in insulin sensitivity
- Change in resting energy expenditure
- Change in intramyocellular fat
- Change in endogenous glucose production
|
| Complete list of historical versions of study NCT00212160 on ClinicalTrials.gov Archive Site |
| Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ] |
| Weight loss |
| |
| The Role of the Omentum in the Treatment of Morbid Obesity |
| The Role of the Omentum in the Treatment of Morbid Obesity |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Obesity |
- Procedure: RYGB with omentectomy
- Procedure: omentectomy
- Procedure: RYGB without omentectomy
|
- Experimental: RYGB with omentectomy
- Active Comparator: RYGB without omentectomy
|
| |
| |
| Recruiting |
| 135 |
| June 2010 |
| June 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 60 Years |
| No |
|
|
| United States |
| |
| NCT00212160 |
| Naji Abumrad, MD, Vanderbilt University Medical Center |
| IRB #040572, 3 RO1 DK 070860-01S1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|
| Principal Investigator: |
Naji N Abumrad, MD |
Vanderbilt University |
|
|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| June 2009 |
