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

This study is not yet open for participant recruitment.
Verified by Rockefeller University, July 2007

Sponsors and Collaborators: Rockefeller University
St. Luke’s Obesity Research Center and New York Hospital
Information provided by: Rockefeller University
ClinicalTrials.gov Identifier: NCT00120562
  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 II

MedlinePlus related topics:   Obesity    Weight Control   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Longitudinal, Defined Population, Prospective Study
Official Title:   A Gene Expression and Metabolic Profile of Weight Loss: Studies of Patients Following Gastric Bypass Surgery

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
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120562

Contacts
Contact: Lanie Fleischer, CSW     800-782-2737     obesity@rockefeller.edu    
Contact: Sagit Zolotov, MD     800-782-2737    

Locations
United States, New York
St. Luke’s Obesity Research Center, NY NY 10023 and New York Hospital     Not yet recruiting
      New York, New York, United States, 10021
      Contact: Lanie Fleischer, CSW     800-782-2737     obesity@mail.rockefeller.edu    
      Contact: Sagit Zolotov, MD     800-782-2737        
      Sub-Investigator: Sagit Zolotov, MD            

Sponsors and Collaborators
Rockefeller University
St. Luke’s Obesity Research Center and New York Hospital

Investigators
Principal Investigator:     Jeffrey M. Friedman, MD     Rockefeller University    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   JFN 0385
First Received:   July 11, 2005
Last Updated:   July 16, 2007
ClinicalTrials.gov Identifier:   NCT00120562
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on August 28, 2008




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