Body Composition & REE Responses to Bariatric Surgery
2 other identifiers
observational
106
1 country
1
Brief Summary
The aim of this study is to measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass (FFM) (bone mineral density, skeletal muscle, and specific organs) at 60 months (T60) and 84 months (T84) post-surgery, and to compare compartment sizes with stable weight controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 1, 2019
January 1, 2019
11.3 years
May 20, 2008
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fat and fat-free mass
Approximately 60 months and 84 months post-bariatric surgery
Secondary Outcomes (1)
Adipose tissue distribution
Approximately 60 months and 84 months post-bariatric surgery
Other Outcomes (1)
Resting energy expenditure
Approximately 60 months and 84 months post-bariatric surgery
Study Arms (1)
LABS patients
Bariatric surgery patients with 35\>BMI kg/m2\<60 prior to surgery will undergo follow-up post-bariatric surgery.
Interventions
Follow-up of those subjects who had bariatric surgery (as part of the parent LABS trial) immediately following the collection of baseline measures (body composition) in this study. Follow-up body composition measures will be acquired at 60 months and 84 months post-baseline measures (post-surgery).
Eligibility Criteria
Patients who consented and enrolled in the ancillary study, LABS, prior to having bariatric surgery; all came from Weill Cornell and the University of Pittsburgh LABS sites
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (1)
Ashby-Thompson M, Heshka S, Rizkalla B, Zurlo R, Lemos T, Janumala I, Goodpaster B, DeLany J, Courcoulas A, Strain G, Pomp A, Kang P, Lin S, Thornton J, Gallagher D. Validity of dual-energy x-ray absorptiometry for estimation of visceral adipose tissue and visceral adipose tissue change after surgery-induced weight loss in women with severe obesity. Obesity (Silver Spring). 2022 May;30(5):1057-1065. doi: 10.1002/oby.23415. Epub 2022 Apr 6.
PMID: 35384351DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Delany, PhD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Nutritional Medicine
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 22, 2008
Study Start
October 1, 2006
Primary Completion
January 1, 2018
Study Completion
June 1, 2018
Last Updated
February 1, 2019
Record last verified: 2019-01