Studies of Biological Changes Related to Weight Loss After Gastric Bypass Surgery

Obesity Clinical Trial

Official title:

A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00120562
• Other study ID #: JFN 0385
• Status: Terminated
• Phase: Phase 2
• First received: July 11, 2005
• Last updated: August 27, 2009
• Start date: July 2007

Study information

• Verified date: August 2009
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 years old

• Subjects approved for gastric bypass surgery

Exclusion Criteria:

• Subjects not approved for gastric bypass surgery

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• Gastric Bypass Surgery

Locations

Country	Name	City	State
United States	St. Luke's Obesity Research Center, NY NY 10023 and New York Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	New York Obesity and Nutrition Research Center

Country where clinical trial is conducted

United States, 

External Links

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