Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge|
- Reactive hypoglycemia status and ratio between the maximum serum glucose level and the minimum serum glucose level during glucose tolerance testing. [ Time Frame: 6, 9, and 12 months post-operatively ] [ Designated as safety issue: Yes ]
- Insulin resistance [ Time Frame: 6, 9, and 12 months post-operatively ] [ Designated as safety issue: Yes ]
- subjective symptoms of hypoglycemia during glucose tolerance testing [ Time Frame: 6, 9, and 12 months post-op ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Pyloric-sparing vs. non-pyloric sparing
Pyloric: SG & DS Non-pyloric: RYGB
Clinical Trial Objective:
The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.
Clinical Trial Design:
This is a prospective, non-randomized, clinical trial.
|United States, New York|
|Lenox Hill Hospital 186 E76th Street, 1st Floor|
|New York City, New York, United States, 10021|
|Principal Investigator:||Mitchell Roslin, MD||Lenox Hill Hospital|