Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120562
Status:
TERMINATED
Last Update Posted:
2009-08-28
First Post:
2005-07-11
Brief Title:
Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
A Gene Expression and Metabolic Profile of Weight Loss Studies of Patients Following Gastric Bypass Surgery
Status:
TERMINATED
Status Verified Date:
2009-08
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:
Weight loss achieved by dieting induces multiple changes These changes include a decrease in metabolic rate the rate in which the body burns its calories an increase in appetite and other physiological and hormonal changes that may be the cause of failure in dieting Many of these parameters that have never been evaluated when weight is lost after gastric bypass surgery will be tested in this study
Detailed Description:
While gastric bypass surgery GBS is known to be highly effective in achieving significant weight loss it is also associated with other biologic changes that occur in the body when weight is lost In this study subjects undergoing gastric bypass surgery will be followed throughout the weight loss period They will undergo four detailed medical evaluations to assess changes in several biological systems that occur in the body when weight is lost
The initial assessment will be performed before the surgery testing period 1 After surgery is completed subjects will attend clinic visits at the Rockefeller University outpatient clinic During these visits weight and leptin levels will be monitored Two additional assessments will be performed during weight loss when subjects lose 10 and 20 of their initial weight testing periods 2 and 3 respectively A final evaluation will be performed after weight is stabilized about 18 months after the surgery is completed testing period 4 Each testing period will be performed over a 2 week period in an inpatient setting at the Rockefeller University Hospital During testing periods subjects will undergo a series of metabolic behavioral hormonal immune and molecular tests to evaluate changes that occur in the body after weight loss Subjects will receive monetary compensation for participating in the study
The initial assessment will be performed before the surgery testing period 1 After surgery is completed subjects will attend clinic visits at the Rockefeller University outpatient clinic During these visits weight and leptin levels will be monitored Two additional assessments will be performed during weight loss when subjects lose 10 and 20 of their initial weight testing periods 2 and 3 respectively A final evaluation will be performed after weight is stabilized about 18 months after the surgery is completed testing period 4 Each testing period will be performed over a 2 week period in an inpatient setting at the Rockefeller University Hospital During testing periods subjects will undergo a series of metabolic behavioral hormonal immune and molecular tests to evaluate changes that occur in the body after weight loss Subjects will receive monetary compensation for participating in the study
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