|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00465829 |
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:
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: | Cohort, 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: | August 2009 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Steven Belle, PhD | 412-624-9640 |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Paul D Berk, MD | |
| Cornell University Medical Center | Recruiting |
| New York, New York, United States, 10021 | |
| Principal Investigator: Paul D Berk, MD | |
| United States, North Carolina | |
| East Carolina University | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Principal Investigator: Walter Pories, MD, FACS | |
| United States, North Dakota | |
| Neuropsychiatric Research Institute | Recruiting |
| Fargo, North Dakota, United States, 58107 | |
| Principal Investigator: James E Mitchell, MD | |
| United States, Oregon | |
| Legacy Good Samaritan Hospital | Recruiting |
| Portland, Oregon, United States | |
| Principal Investigator: Bruce Wolfe, MD | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States | |
| Principal Investigator: Bruce Wolfe, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Anita Courcoulas, MD,MPH,FACS | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: David R Flum, MD,MPH,FACS | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: David R. Flum, MD,MPH,FACS | |
| Principal Investigator: | Paul D Berk, MD | Columbia University Medical Center |
| 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
| Responsible Party: | Oregon Health & Science University ( Dr. Bruce Wolfe, LABS Steering Committee Chair ) |
| Study ID Numbers: | DK6657_2 |
| Study First Received: | April 24, 2007 |
| Last Updated: | November 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00465829 |
| Health Authority: | United States: Federal Government |
|
Obesity |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
