Long-term Effects of Bariatric Surgery (LABS-2)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- comparing post-surgical outcomes to pre-operative status
- 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) |
Whole blood, serum, plasma, urine.
| Estimated Enrollment: | 2400 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | June 2014 |
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 |
All bariatric surgical candidates at participating LABS centers who are 18 years or older and have not had prior bariatric surgery.
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| 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 | |
| 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: | November 12, 2012 |
| 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 June 18, 2013