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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120562
First Posted: July 18, 2005
Last Update Posted: August 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
New York Obesity and Nutrition Research Center
Information provided by:
Rockefeller University
  Purpose
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

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Estimated Enrollment: 13
Study Start Date: July 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects not approved for gastric bypass surgery
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, New York
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00120562     History of Changes
Other Study ID Numbers: JFN 0385
First Submitted: July 11, 2005
First Posted: July 18, 2005
Last Update Posted: August 28, 2009
Last Verified: August 2009

Keywords provided by Rockefeller University:
weight loss surgery
gastric bypass surgery

Additional relevant MeSH terms:
Obesity
Body Weight
Weight Loss
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Body Weight Changes