Long-term Effects of Bariatric Surgery (LABS-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00465829
First received: April 24, 2007
Last updated: November 12, 2012
Last verified: November 2012

April 24, 2007
November 12, 2012
March 2006
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Complete list of historical versions of study NCT00465829 on ClinicalTrials.gov Archive Site
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Long-term Effects of Bariatric Surgery
Longitudinal Assessment of Bariatric Surgery (LABS-2)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum, plasma, urine.

Non-Probability Sample

All bariatric surgical candidates at participating LABS centers who are 18 years or older and have not had prior bariatric surgery.

Obesity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2400
June 2014
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465829
DK6657_2, U01DK066557
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Paul D Berk, MD Columbia University
Principal Investigator: Anita Courcoulas, MD,MPH,FACS University of Pittsburgh
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
University of Pittsburgh
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP