ObesityLABS-2NCT00465829
Long-term Effects of Bariatric Surgery
An observational study of Obesity, run by University of Pittsburgh at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 2,458 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2006to Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All bariatric surgical candidates at participating LABS centers who are 18 years or older and have not had prior bariatric surgery.
Who may be able to join
- 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
Who cannot join
- Informed consent not obtained
- Prior bariatric surgery
- Unlikely to comply with follow-up protocol
- Unable to communicate with local study staff
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 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
University of Washington
Seattle, Washington, 98195
Virginia Mason Medical Center
Seattle, Washington, 98195
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startMar 2006
- Primary completionJan 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for 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
- 2,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Belle, University of Pittsburgh
- Investigators
- Paul D Berk, MD, Principal investigator, Columbia UniversityAnita Courcoulas, MD,MPH,FACS, Principal investigator, University of Pittsburgh Medical CenterDavid R Flum, MD,MPH,FACS, Principal investigator, University of WashingtonJames E Mitchell, MD, Principal investigator, Neuropsychiatric Research InstituteBruce M Wolfe, MD,FACS, Principal investigator, Oregon Health and Science UniversityWalter J Pories, MD,FACS, Principal investigator, East Carolina Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465829
- Sponsor's protocol ID
- DK6657_2
- Other IDs
- U01DK066557
- Acronym
- LABS-2
- Status last verified
- Sep 2016
- First submitted
- 24 Apr 2007
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data deposited in NIDDK funded data repository
Publications
White GE, Courcoulas AP, Broskey NT, Rogan SC, Jeyabalan A, King WC. Maternal and Neonatal Outcomes of Pregnancy within 7 years after Roux-Y Gastric Bypass or Sleeve Gastrectomy Surgery. Obes Surg. 2023 Jun;33(6):1764-1772. doi: 10.1007/s11695-023-06575-6. Epub 2023 Apr 4.
PubMed 37014543Wolfe MB, Williams TJ, Dewey EN, Mitchell JE, Pomp A, Wolfe BM. Health change awareness and its association with weight loss following bariatric surgery. Health Psychol. 2023 Jun;42(6):403-410. doi: 10.1037/hea0001279. Epub 2023 Mar 27.
PubMed 36972088Purnell JQ, Dewey EN, Laferrere B, Selzer F, Flum DR, Mitchell JE, Pomp A, Pories WJ, Inge T, Courcoulas A, Wolfe BM. Diabetes Remission Status During Seven-year Follow-up of the Longitudinal Assessment of Bariatric Surgery Study. J Clin Endocrinol Metab. 2021 Mar 8;106(3):774-788. doi: 10.1210/clinem/dgaa849.
PubMed 33270130Smith KE, Mason TB, Cao L, Crosby RD, Steffen KJ, Garcia L, King WC, Mitchell JE. Trajectories of depressive symptoms and relationships with weight loss in the seven years after bariatric surgery. Obes Res Clin Pract. 2020 Sep-Oct;14(5):456-461. doi: 10.1016/j.orcp.2020.08.007. Epub 2020 Sep 12.
PubMed 32933863Bjornstad P, Nehus E, Jenkins T, Mitsnefes M, Moxey-Mims M, Dixon JB, Inge TH. Five-year kidney outcomes of bariatric surgery differ in severely obese adolescents and adults with and without type 2 diabetes. Kidney Int. 2020 May;97(5):995-1005. doi: 10.1016/j.kint.2020.01.016. Epub 2020 Feb 3.
PubMed 32229096Dewberry LC, Jalivand A, Gupta R, Jenkins TM, Beamish A, Inge TH, Courcoulas A, Helmrath M, Brandt ML, Harmon CM, Chen M, Dixon JB, Zeller M, Michalsky MP. Weight Loss and Health Status 5 Years After Adjustable Gastric Banding in Adolescents. Obes Surg. 2020 Jun;30(6):2388-2394. doi: 10.1007/s11695-020-04504-5.
PubMed 32124210Heshka S, Lemos T, Astbury NM, Widen E, Davidson L, Goodpaster BH, DeLany JP, Strain GW, Pomp A, Courcoulas AP, Lin S, Janumala I, Yu W, Kang P, Thornton JC, Gallagher D. Resting Energy Expenditure and Organ-Tissue Body Composition 5 Years After Bariatric Surgery. Obes Surg. 2020 Feb;30(2):587-594. doi: 10.1007/s11695-019-04217-4.
PubMed 31617114Steffen KJ, King WC, White GE, Subak LL, Mitchell JE, Courcoulas AP, Flum DR, Strain G, Sarwer DB, Kolotkin RL, Pories W, Huang AJ. Changes in Sexual Functioning in Women and Men in the 5 Years After Bariatric Surgery. JAMA Surg. 2019 Jun 1;154(6):487-498. doi: 10.1001/jamasurg.2018.1162.
PubMed 30785625Davidson LE, Yu W, Goodpaster BH, DeLany JP, Widen E, Lemos T, Strain GW, Pomp A, Courcoulas AP, Lin S, Janumala I, Thornton JC, Gallagher D. Fat-Free Mass and Skeletal Muscle Mass Five Years After Bariatric Surgery. Obesity (Silver Spring). 2018 Jul;26(7):1130-1136. doi: 10.1002/oby.22190. Epub 2018 May 30.
PubMed 29845744Courcoulas AP, King WC, Belle SH, Berk P, Flum DR, Garcia L, Gourash W, Horlick M, Mitchell JE, Pomp A, Pories WJ, Purnell JQ, Singh A, Spaniolas K, Thirlby R, Wolfe BM, Yanovski SZ. Seven-Year Weight Trajectories and Health Outcomes in the Longitudinal Assessment of Bariatric Surgery (LABS) Study. JAMA Surg. 2018 May 1;153(5):427-434. doi: 10.1001/jamasurg.2017.5025.
PubMed 29214306Menke MN, King WC, White GE, Gosman GG, Courcoulas AP, Dakin GF, Flum DR, Orcutt MJ, Pomp A, Pories WJ, Purnell JQ, Steffen KJ, Wolfe BM, Yanovski SZ. Contraception and Conception After Bariatric Surgery. Obstet Gynecol. 2017 Nov;130(5):979-987. doi: 10.1097/AOG.0000000000002323.
PubMed 29016506King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Elder KA, Flum DR, Hinojosa MW, Mitchell JE, Pories WJ, Wolfe BM, Yanovski SZ. Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity. JAMA. 2016 Apr 5;315(13):1362-71. doi: 10.1001/jama.2016.3010.
PubMed 27046364Courcoulas AP, Christian NJ, O'Rourke RW, Dakin G, Patchen Dellinger E, Flum DR, Melissa Kalarchian PD, Mitchell JE, Patterson E, Pomp A, Pories WJ, Spaniolas K, Steffen K, Wolfe BM, Belle SH. Preoperative factors and 3-year weight change in the Longitudinal Assessment of Bariatric Surgery (LABS) consortium. Surg Obes Relat Dis. 2015 Sep-Oct;11(5):1109-18. doi: 10.1016/j.soard.2015.01.011. Epub 2015 Jan 23.
PubMed 25824474Mitchell JE, King WC, Chen JY, Devlin MJ, Flum D, Garcia L, Inabet W, Pender JR, Kalarchian MA, Khandelwal S, Marcus MD, Schrope B, Strain G, Wolfe B, Yanovski S. Course of depressive symptoms and treatment in the longitudinal assessment of bariatric surgery (LABS-2) study. Obesity (Silver Spring). 2014 Aug;22(8):1799-806. doi: 10.1002/oby.20738. Epub 2014 Mar 25.
PubMed 24634371Courcoulas AP, Christian NJ, Belle SH, Berk PD, Flum DR, Garcia L, Horlick M, Kalarchian MA, King WC, Mitchell JE, Patterson EJ, Pender JR, Pomp A, Pories WJ, Thirlby RC, Yanovski SZ, Wolfe BM; Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013 Dec 11;310(22):2416-25. doi: 10.1001/jama.2013.280928.
PubMed 24189773
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Bariatric Surgery (LABS-2)
- ClinicalTrials.gov ID
- NCT00465829
- Acronym / sponsor ID
- LABS-2 / DK6657_2
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,458 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2006
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Apr 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All bariatric surgical candidates at participating LABS centers who are 18 years or older and have not had prior bariatric surgery.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Informed consent not obtained
- Prior bariatric surgery
- Unlikely to comply with follow-up protocol
- Unable to communicate with local study staff
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 21 Sep 2016.
- Derived from this study: PubMed 37014543White GE, Courcoulas AP, Broskey NT, Rogan SC, Jeyabalan A, King WC. Maternal and Neonatal Outcomes of Pregnancy within 7 years after Roux-Y Gastric Bypass or Sleeve Gastrectomy Surgery. Obes Surg. 2023 Jun;33(6):1764-1772. doi: 10.1007/s11695-023-06575-6. Epub 2023 Apr 4.
- Derived from this study: PubMed 36972088Wolfe MB, Williams TJ, Dewey EN, Mitchell JE, Pomp A, Wolfe BM. Health change awareness and its association with weight loss following bariatric surgery. Health Psychol. 2023 Jun;42(6):403-410. doi: 10.1037/hea0001279. Epub 2023 Mar 27.
- Derived from this study: PubMed 33270130Purnell JQ, Dewey EN, Laferrere B, Selzer F, Flum DR, Mitchell JE, Pomp A, Pories WJ, Inge T, Courcoulas A, Wolfe BM. Diabetes Remission Status During Seven-year Follow-up of the Longitudinal Assessment of Bariatric Surgery Study. J Clin Endocrinol Metab. 2021 Mar 8;106(3):774-788. doi: 10.1210/clinem/dgaa849.
- Derived from this study: PubMed 32933863Smith KE, Mason TB, Cao L, Crosby RD, Steffen KJ, Garcia L, King WC, Mitchell JE. Trajectories of depressive symptoms and relationships with weight loss in the seven years after bariatric surgery. Obes Res Clin Pract. 2020 Sep-Oct;14(5):456-461. doi: 10.1016/j.orcp.2020.08.007. Epub 2020 Sep 12.
- Derived from this study: PubMed 32229096Bjornstad P, Nehus E, Jenkins T, Mitsnefes M, Moxey-Mims M, Dixon JB, Inge TH. Five-year kidney outcomes of bariatric surgery differ in severely obese adolescents and adults with and without type 2 diabetes. Kidney Int. 2020 May;97(5):995-1005. doi: 10.1016/j.kint.2020.01.016. Epub 2020 Feb 3.
- Derived from this study: PubMed 32124210Dewberry LC, Jalivand A, Gupta R, Jenkins TM, Beamish A, Inge TH, Courcoulas A, Helmrath M, Brandt ML, Harmon CM, Chen M, Dixon JB, Zeller M, Michalsky MP. Weight Loss and Health Status 5 Years After Adjustable Gastric Banding in Adolescents. Obes Surg. 2020 Jun;30(6):2388-2394. doi: 10.1007/s11695-020-04504-5.
- Derived from this study: PubMed 31617114Heshka S, Lemos T, Astbury NM, Widen E, Davidson L, Goodpaster BH, DeLany JP, Strain GW, Pomp A, Courcoulas AP, Lin S, Janumala I, Yu W, Kang P, Thornton JC, Gallagher D. Resting Energy Expenditure and Organ-Tissue Body Composition 5 Years After Bariatric Surgery. Obes Surg. 2020 Feb;30(2):587-594. doi: 10.1007/s11695-019-04217-4.
- Derived from this study: PubMed 30785625Steffen KJ, King WC, White GE, Subak LL, Mitchell JE, Courcoulas AP, Flum DR, Strain G, Sarwer DB, Kolotkin RL, Pories W, Huang AJ. Changes in Sexual Functioning in Women and Men in the 5 Years After Bariatric Surgery. JAMA Surg. 2019 Jun 1;154(6):487-498. doi: 10.1001/jamasurg.2018.1162.
- Derived from this study: PubMed 29845744Davidson LE, Yu W, Goodpaster BH, DeLany JP, Widen E, Lemos T, Strain GW, Pomp A, Courcoulas AP, Lin S, Janumala I, Thornton JC, Gallagher D. Fat-Free Mass and Skeletal Muscle Mass Five Years After Bariatric Surgery. Obesity (Silver Spring). 2018 Jul;26(7):1130-1136. doi: 10.1002/oby.22190. Epub 2018 May 30.
- Derived from this study: PubMed 29214306Courcoulas AP, King WC, Belle SH, Berk P, Flum DR, Garcia L, Gourash W, Horlick M, Mitchell JE, Pomp A, Pories WJ, Purnell JQ, Singh A, Spaniolas K, Thirlby R, Wolfe BM, Yanovski SZ. Seven-Year Weight Trajectories and Health Outcomes in the Longitudinal Assessment of Bariatric Surgery (LABS) Study. JAMA Surg. 2018 May 1;153(5):427-434. doi: 10.1001/jamasurg.2017.5025.
- Derived from this study: PubMed 29016506Menke MN, King WC, White GE, Gosman GG, Courcoulas AP, Dakin GF, Flum DR, Orcutt MJ, Pomp A, Pories WJ, Purnell JQ, Steffen KJ, Wolfe BM, Yanovski SZ. Contraception and Conception After Bariatric Surgery. Obstet Gynecol. 2017 Nov;130(5):979-987. doi: 10.1097/AOG.0000000000002323.
- Derived from this study: PubMed 27046364King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Elder KA, Flum DR, Hinojosa MW, Mitchell JE, Pories WJ, Wolfe BM, Yanovski SZ. Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity. JAMA. 2016 Apr 5;315(13):1362-71. doi: 10.1001/jama.2016.3010.
- Study web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data deposited in NIDDK funded data repository
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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.
Paul D Berk, MD principal investigator
Columbia University
Anita Courcoulas, MD,MPH,FACS principal investigator
University of Pittsburgh Medical Center
David R Flum, MD,MPH,FACS principal investigator
University of Washington
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Pittsburgh at 9 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 3 inclusion and 4 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 NCT00465829, which also lists 16 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 21 Sep 2016; AzTrials last refreshed its copy on 2 Nov 2026.