Morbid ObesityLABS-1NCT00433810
Longitudinal Assessment of Bariatric Surgery
An observational study of Morbid Obesity, run by University of Pittsburgh at 10 sites in United States.
Trial summary
The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 5,102 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible bariatric surgery candidates at the participating LABS clinical sites.
Who may be able to join
- All patients age 18 years or older, eligible and undergoing bariatric surgery performed by a LABS-certified surgeon.
Who cannot join
- Patients who do not provide informed consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Neuropsychiatric Research Institute
Fargo, North Dakota, 58107
East Carolina University
Greenville, North Carolina, 27834
Cornell University Medical Center
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Legacy Good Samaritan Hospital
Portland, Oregon
Oregon Health and Science University
Portland, Oregon
Sacramento Bariatric
Sacramento, California
University of Washington
Seattle, Washington, 98195
Virginia Mason Medical Center
Seattle, Washington, 98195
About this study
Official title: Longitudinal Assessment of Bariatric Surgery (LABS-1)
The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.
Read the detailed description
The primary objectives of this study are to assess the safety of bariatric surgery by estimating the prevalence of short term adverse outcomes in a multicenter cohort of patients undergoing bariatric surgical procedures and to determine the associations between short term adverse outcomes after bariatric surgery and both clinical/demographic patient characteristics and features of operative/perioperative care
Funds are not available to pay for the surgery for patients, only to address research questions.
- Conditions
- Morbid Obesity
- Keywords
- obesity, bariatric surgery, 30-day mortality
- Medical subject headings
- Obesity, Morbid, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startMar 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Bruce Wolfe, MD, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433810
- Sponsor's protocol ID
- DK66557 (completed)
- Other IDs
- U01DK066557
- Acronym
- LABS-1
- Status last verified
- Dec 2010
- First submitted
- 9 Feb 2007
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walker E, Elman M, Takemoto EE, Fennern E, Mitchell JE, Pories WJ, Ahmed B, Pomp A, Wolfe BM. Bariatric Surgery Among Medicare Subgroups: Short- and Long-Term Outcomes. Obesity (Silver Spring). 2019 Nov;27(11):1820-1827. doi: 10.1002/oby.22613. Epub 2019 Sep 27.
PubMed 31562705O'Rourke RW, Johnson GS, Purnell JQ, Courcoulas AP, Dakin GF, Garcia L, Hinojosa M, Mitchell JE, Pomp A, Pories WJ, Spaniolas K, Flum DR, Wahed AS, Wolfe BM. Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes. Int J Obes (Lond). 2019 Feb;43(2):285-296. doi: 10.1038/s41366-018-0088-z. Epub 2018 May 17.
PubMed 29777230Purnell JQ, Johnson GS, Wahed AS, Dalla Man C, Piccinini F, Cobelli C, Prigeon RL, Goodpaster BH, Kelley DE, Staten MA, Foster-Schubert KE, Cummings DE, Flum DR, Courcoulas AP, Havel PJ, Wolfe BM. Prospective evaluation of insulin and incretin dynamics in obese adults with and without diabetes for 2 years after Roux-en-Y gastric bypass. Diabetologia. 2018 May;61(5):1142-1154. doi: 10.1007/s00125-018-4553-y. Epub 2018 Feb 10.
PubMed 29428999Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54. doi: 10.1056/NEJMoa0901836.
PubMed 19641201
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Bariatric Surgery (LABS-1)
- ClinicalTrials.gov ID
- NCT00433810
- Acronym / sponsor ID
- LABS-1 / DK66557 (completed)
- Conditions
- Morbid Obesity
- Keywords
- obesity, bariatric surgery, 30-day mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,102 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.
Detailed description
The primary objectives of this study are to assess the safety of bariatric surgery by estimating the prevalence of short term adverse outcomes in a multicenter cohort of patients undergoing bariatric surgical procedures and to determine the associations between short term adverse outcomes after bariatric surgery and both clinical/demographic patient characteristics and features of operative/perioperative care
Funds are not available to pay for the surgery for patients, only to address research questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible bariatric surgery candidates at the participating LABS clinical sites.
Key inclusion criteria (1 listed)
- All patients age 18 years or older, eligible and undergoing bariatric surgery performed by a LABS-certified surgeon.
Key exclusion criteria (1 listed)
- Patients who do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
- Derived from this study: PubMed 31562705Walker E, Elman M, Takemoto EE, Fennern E, Mitchell JE, Pories WJ, Ahmed B, Pomp A, Wolfe BM. Bariatric Surgery Among Medicare Subgroups: Short- and Long-Term Outcomes. Obesity (Silver Spring). 2019 Nov;27(11):1820-1827. doi: 10.1002/oby.22613. Epub 2019 Sep 27.
- Derived from this study: PubMed 29777230O'Rourke RW, Johnson GS, Purnell JQ, Courcoulas AP, Dakin GF, Garcia L, Hinojosa M, Mitchell JE, Pomp A, Pories WJ, Spaniolas K, Flum DR, Wahed AS, Wolfe BM. Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes. Int J Obes (Lond). 2019 Feb;43(2):285-296. doi: 10.1038/s41366-018-0088-z. Epub 2018 May 17.
- Derived from this study: PubMed 29428999Purnell JQ, Johnson GS, Wahed AS, Dalla Man C, Piccinini F, Cobelli C, Prigeon RL, Goodpaster BH, Kelley DE, Staten MA, Foster-Schubert KE, Cummings DE, Flum DR, Courcoulas AP, Havel PJ, Wolfe BM. Prospective evaluation of insulin and incretin dynamics in obese adults with and without diabetes for 2 years after Roux-en-Y gastric bypass. Diabetologia. 2018 May;61(5):1142-1154. doi: 10.1007/s00125-018-4553-y. Epub 2018 Feb 10.
- Derived from this study: PubMed 19641201Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54. doi: 10.1056/NEJMoa0901836.
- Study web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Wolfe, MD study chair
Oregon Health and Science University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by University of Pittsburgh at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00433810, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2010.