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Trial record 1 of 1 for:    NCT00465829
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Long-term Effects of Bariatric Surgery (LABS-2)

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ClinicalTrials.gov Identifier: NCT00465829
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : September 21, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven Belle, University of Pittsburgh

Study Description
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Brief Summary:

The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by:

  1. comparing post-surgical outcomes to pre-operative status
  2. examining risks and benefits of surgery.

LABS-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status.

Funds are not available to pay for the surgery for patients, only to address research questions.


Condition or disease
Obesity

Detailed Description:
The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort, approximately 2,400 patients, will be recruited over 3 years. LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic, pathologic and genomic testing of other hypotheses.
Study Design
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Study Type : Observational
Actual Enrollment : 2458 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Bariatric Surgery (LABS-2)
Study Start Date : March 2006
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, urine.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All bariatric surgical candidates at participating LABS centers who are 18 years or older and have not had prior bariatric surgery.
Criteria

Inclusion Criteria:

  • Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon
  • Previous enrollment in LABS-1
  • Selected by algorithm to be included in LABS-2

Exclusion Criteria:

  • Informed consent not obtained
  • Prior bariatric surgery
  • Unlikely to comply with follow-up protocol
  • Unable to communicate with local study staff
Contacts and Locations
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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): NCT00465829


Locations
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United States, New York
Cornell University Medical Center
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58107
United States, Oregon
Legacy Good Samaritan Hospital
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Paul D Berk, MD Columbia University
Principal Investigator: Anita Courcoulas, MD,MPH,FACS University of Pittsburgh Medical Center
Principal Investigator: David R Flum, MD,MPH,FACS University of Washington
Principal Investigator: James E Mitchell, MD Neuropsychiatric Research Institute
Principal Investigator: Bruce M Wolfe, MD,FACS Oregon Health and Science University
Principal Investigator: Walter J Pories, MD,FACS East Carolina Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven Belle, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00465829    
Other Study ID Numbers: DK6657_2
U01DK066557 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data deposited in NIDDK funded data repository
Keywords provided by Steven Belle, University of Pittsburgh:
Obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight