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Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery
This study has been terminated.
Study NCT00120562   Information provided by Rockefeller University
First Received: July 11, 2005   Last Updated: August 27, 2009   History of Changes

July 11, 2005
August 27, 2009
July 2007
 
 
 
Complete list of historical versions of study NCT00120562 on ClinicalTrials.gov Archive Site
 
 
 
Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery
A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery

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.

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.

Phase II
Observational
Other, Prospective
  • Obesity
  • Morbid Obesity
  • Weight Loss
Procedure: Gastric Bypass Surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
13
 
 

Inclusion Criteria:

  • 18 - 65 years old
  • Subjects approved for gastric bypass surgery

Exclusion Criteria:

  • Subjects not approved for gastric bypass surgery
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120562
 
JFN 0385
Rockefeller University
St. Luke’s Obesity Research Center and New York Hospital
Principal Investigator: Jeffrey M. Friedman, MD Rockefeller University
Rockefeller University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP