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

This study has been terminated.
Sponsor:
Collaborator:
New York Obesity and Nutrition Research Center
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00120562
First received: July 11, 2005
Last updated: August 27, 2009
Last verified: August 2009
  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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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:
Obesity
Obesity, Morbid
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 28, 2014