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.

Condition	Intervention	Phase
Obesity Morbid Obesity Weight Loss	Procedure: Gastric Bypass Surgery	Phase II

Further Study Details: 

Expected Total Enrollment:  13

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects not approved for gastric bypass surgery

Please refer to this study by ClinicalTrials.gov identifier  NCT00120562

Lanie Fleischer, CSW      800-872-2737    obesity@rockefeller.edu
Sagit Zolotov, MD      800-872-2737 

New York
      St. Luke’s Obesity Research Center, NY NY 10023 and New York Hospital, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Jeffrey M. Friedman, MD,  Principal Investigator,  Rockefeller University   

Study ID Numbers:  JFN 0385
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120562
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26