Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery
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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 2 |
Study Type: | Observational |
Study Design: | Time Perspective: Prospective |
Official Title: | A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery |
Estimated Enrollment: | 13 |
Study Start Date: | July 2007 |
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 to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 18 - 65 years old
- Subjects approved for gastric bypass surgery
Inclusion Criteria:
- 18 - 65 years old
- Subjects approved for gastric bypass surgery
Exclusion Criteria:
- Subjects not approved for gastric bypass surgery
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 |
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00120562 History of Changes |
Other Study ID Numbers: | JFN 0385 |
Study First Received: | July 11, 2005 |
Last Updated: | August 27, 2009 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Rockefeller University:
weight loss surgery gastric bypass surgery |
Additional relevant MeSH terms:
Body Weight Obesity Obesity, Morbid Weight Loss Signs and Symptoms |
Overnutrition Nutrition Disorders Overweight Body Weight Changes |
ClinicalTrials.gov processed this record on October 16, 2012