Ignite Creation Date:
2024-05-05 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00675558
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2008-05-07
Brief Title:
Bariatric Surgery for Morbid Obesity
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Bariatric Surgery for Morbid Obesity Clinical and Pathophysiologic Consequences
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Despite progress in understanding the pathophysiology of obesity current strategies for its medical management remain largely ineffective Most efforts have focused on reducing caloric intake or increasing energy expenditure either through behavior modification eg dieting regular exercise alone or augmented by pharmacologic efforts to decrease appetite inhibit fat absorption or alter metabolism Bariatric surgery remains the only proven long term treatment of morbid obesity
Super morbidly obese SMO Body Mass Index BMI 50 and super super morbidly obese SSMO BMI 60 patients lose considerable weight but stabilize at Body Mass Indexes BMIs that are still obese or even morbidly obese after risking considerable morbidity andor mortality Among commonly performed bariatric surgeries a laparoscopic two-stage procedure in which an initial restrictive procedure is followed after a weight loss of 100 lbs by a more complex procedure that creates malabsorption is gaining interest Initial studies have demonstrated very good long-term weight loss with minimal morbidity and no operative mortality in these high risk patients
Availability of biospecimens obtained at each stage of this protocol will allow participating scientists a unique opportunity to test in human tissues hypotheses developed in animals Studies proposed under this application focus on fatty acids and overall fat disposition in fat depots adipose tissue of your body and the role of adipose tissue hormones and inflammatory processes in obesity and its associated health related issues
Super morbidly obese SMO Body Mass Index BMI 50 and super super morbidly obese SSMO BMI 60 patients lose considerable weight but stabilize at Body Mass Indexes BMIs that are still obese or even morbidly obese after risking considerable morbidity andor mortality Among commonly performed bariatric surgeries a laparoscopic two-stage procedure in which an initial restrictive procedure is followed after a weight loss of 100 lbs by a more complex procedure that creates malabsorption is gaining interest Initial studies have demonstrated very good long-term weight loss with minimal morbidity and no operative mortality in these high risk patients
Availability of biospecimens obtained at each stage of this protocol will allow participating scientists a unique opportunity to test in human tissues hypotheses developed in animals Studies proposed under this application focus on fatty acids and overall fat disposition in fat depots adipose tissue of your body and the role of adipose tissue hormones and inflammatory processes in obesity and its associated health related issues
Detailed Description:
Despite rapidly growing interest in the pathogenesis of the obesity epidemic the pathophysiology of obesity remain poorly understood While studies in animals have yielded many insights it has become clear that human obesity differs in important ways from that in rodents Bariatric surgery offers better outcomes but in the highest grades of obesity BMI50 remains a high risk undertaking with 5 operative mortality being reported when commonly performed bariatric surgical approaches are employed By contrast laparoscopic two-stage approach has resulted in excellent weight loss minimal morbidity and 1 mortality
Availability of blood samples and biopsies of omental and subcutaneous fat from each of the paired bariatric procedures in this protocol will provide a unique opportunity to study key issues in human obesity This study tests the broad hypothesis that there are significant and as yet unrecognized differences between the pathobiology of obesity in man and rodents the identification of which may lead to new therapeutic targets Accordingly to facilitate comparisons with aspects of obesity we have already investigated in animal models we will 1 seek fat depot specific differences in Long Chain Fatty Acid LCFA disposition macrophage infiltration and adipokine production in obesity and after surgery-induced weight loss in man and correlate them with the presenceseverity of the metabolic syndrome MetSyn and 2 quantify the relative significance and response to weight loss of different mechanisms contributing to hepatic steatosis and the elevated triglycerides TG and reduced High-Density Lipoprotein HDL typical of obesity and MetSyn
Availability of blood samples and biopsies of omental and subcutaneous fat from each of the paired bariatric procedures in this protocol will provide a unique opportunity to study key issues in human obesity This study tests the broad hypothesis that there are significant and as yet unrecognized differences between the pathobiology of obesity in man and rodents the identification of which may lead to new therapeutic targets Accordingly to facilitate comparisons with aspects of obesity we have already investigated in animal models we will 1 seek fat depot specific differences in Long Chain Fatty Acid LCFA disposition macrophage infiltration and adipokine production in obesity and after surgery-induced weight loss in man and correlate them with the presenceseverity of the metabolic syndrome MetSyn and 2 quantify the relative significance and response to weight loss of different mechanisms contributing to hepatic steatosis and the elevated triglycerides TG and reduced High-Density Lipoprotein HDL typical of obesity and MetSyn
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 |
|---|---|---|---|
| R01DK072526 | NIH | None | httpsreporternihgovquickSearchR01DK072526 |