Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212160
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2005-09-13
Brief Title:
The Role of the Omentum in the Treatment of Morbid Obesity
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The Role of the Omentum in the Treatment of Morbid Obesity
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 omentectomyno omentectomy A post hoc data power analysis determined that this number of subjects is sufficient for data analysis
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 omentectomyno omentectomy A post hoc data power analysis determined that this number of subjects is sufficient for data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01DK070860-01S1 | NIH | None | httpsreporternihgovquickSearch3R01DK070860-01S1 |
| R01DK070860 | NIH | None | None |