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

Sponsor

Rockefeller University (Other)

Overall Status

Terminated

CT.gov ID

NCT00120562

Collaborator

New York Obesity and Nutrition Research Center (Other)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Morbid Obesity Weight Loss	Procedure: Gastric Bypass Surgery

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

13 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 - 65 years old
Subjects approved for gastric bypass surgery

Exclusion Criteria:

Subjects not approved for gastric bypass surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's Obesity Research Center, NY NY 10023 and New York Hospital	New York	New York	United States	10021

Sponsors and Collaborators

Rockefeller University
New York Obesity and Nutrition Research Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00120562

Other Study ID Numbers:

JFN 0385

First Posted:

Jul 18, 2005

Last Update Posted:

Aug 28, 2009

Last Verified:

Aug 1, 2009

Keywords provided by , ,

weight loss surgery

gastric bypass surgery

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2009