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: July 22, 2014
Last verified: July 2014
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Bariatric Surgery (LABS-2)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma, urine.


Estimated Enrollment: 2400
Study Start Date: March 2006
Estimated Study Completion Date: December 2014
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00465829

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Cornell University Medical Center
New York, New York, United States, 10021
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
Investigators
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
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00465829     History of Changes
Other Study ID Numbers: DK6657_2, U01DK066557
Study First Received: April 24, 2007
Last Updated: July 22, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014