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Body Composition & REE Responses to Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT00682058
Recruitment Status : Active, not recruiting
First Posted : May 22, 2008
Last Update Posted : June 3, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Information provided by (Responsible Party):
Dympna Gallagher, Columbia University

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.

Condition or disease Intervention/treatment
Weight Loss Weight Change Other: Follow-up post-bariatric surgery

Detailed Description:
Consenting, eligible patients previously enrolled in the ancillary study, "Longitudinal Assessment of Bariatric Surgery" (LABS), from Weill Cornell and the University of Pittsburgh will undergo the following measures: total body water by deuterium dilution (fat and fat-free mass (FFM)), extracellular water by sodium bromide tracer, body density by the BodPod, whole-body magnetic resonance imaging (MRI) (adipose tissue and its distribution; skeletal muscle mass; mass of liver, kidneys, heart, and brain), dual energy-X-ray absorptiometry (femur bone mineral density (BMD), total body fat, fat-free mass, and bone mineral content), and resting energy expenditure (REE). MRI will describe body composition changes at the tissue/organ level and adipose tissue distribution allowing us to address questions of biological and clinical importance including the body composition changes' influences on REE. The specific aims are to: 1) measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and FFM (including bone mineral density, skeletal muscle, and specific organs) at T60 and T84 months following surgery, and also to compare compartment sizes with those seen in stable weight controls; 2) measure the amount of change in REE at T60 and T84 compared to T0, following weight loss induced by bariatric surgery and to determine its relation to changes in body composition compartments, and its duration over the follow-up period. Secondary research questions relate to changes in cardiac structure and function, physical activity associations with skeletal muscle changes, and adipose tissue depot changes as predictors of cardiometabolic parameters (glucose metabolism and serum lipid composition). Subjects will be women and men (n=100) equally distributed between the New York and Pittsburgh sites.

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body Composition & REE Responses to Bariatric Surgery
Study Start Date : October 2006
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
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).
Other Name: Observational at this time with no intervention



Primary Outcome Measures :
  1. Fat and fat-free mass [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ]

Secondary Outcome Measures :
  1. Adipose tissue distribution [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ]

Other Outcome Measures:
  1. Resting energy expenditure [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria
  • Had to have been enrolled in the ancillary study prior to having bariatric surgery
  • Are able to come to the laboratory for testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682058


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Investigators
Study Director: James Delany, PhD University of Pittsburgh

Responsible Party: Dympna Gallagher, Associate Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00682058     History of Changes
Other Study ID Numbers: AAAO1655
R01DK072507 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dympna Gallagher, Columbia University:
body composition
weight loss
fat
fat distribution
fat free mass
organ
resting energy expenditure

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms