Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT00120562|
Recruitment Status : Terminated
First Posted : July 18, 2005
Last Update Posted : August 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Obesity Morbid Obesity Weight Loss||Procedure: Gastric Bypass Surgery||Phase 2|
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.
|Study Type :||Observational|
|Estimated Enrollment :||13 participants|
|Official Title:||A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery|
|Study Start Date :||July 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120562
|United States, New York|
|St. Luke's Obesity Research Center, NY NY 10023 and New York Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Jeffrey M. Friedman, MD||Rockefeller University|