NCT00682058

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

11.3 years

First QC Date

May 20, 2008

Last Update Submit

January 30, 2019

Conditions

Keywords

body compositionweight lossfatfat distributionfat free massorganresting energy expenditure

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.

Other: 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).

Also known as: Observational at this time with no intervention
LABS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

* Had to have been enrolled in the ancillary study prior to having bariatric surgery * Are able to come to the laboratory for testing.

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

Location

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.

MeSH Terms

Conditions

Weight LossBody Weight ChangesPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James Delany, PhD

    University of Pittsburgh

    STUDY DIRECTOR

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

Locations