Body Composition & REE Responses to Bariatric Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Information provided by (Responsible Party):
Dympna Gallagher, Columbia University
ClinicalTrials.gov Identifier:
NCT00682058
First received: May 20, 2008
Last updated: June 1, 2016
Last verified: June 2016

May 20, 2008
June 1, 2016
October 2006
July 2017   (final data collection date for primary outcome measure)
Fat and fat-free mass [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00682058 on ClinicalTrials.gov Archive Site
Adipose tissue distribution [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ] [ Designated as safety issue: No ]
Not Provided
Resting energy expenditure [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ] [ Designated as safety issue: No ]
Not Provided
 
Body Composition & REE Responses to Bariatric Surgery
Body Composition & REE Responses to Bariatric Surgery
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
  • Weight Loss
  • Weight Change
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
LABS patients
Bariatric surgery patients with 35>BMI kg/m2<60 prior to surgery will undergo follow-up post-bariatric surgery.
Intervention: Other: Follow-up post-bariatric surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
July 2017
July 2017   (final data collection date for primary outcome measure)
  • Had to have been enrolled in the ancillary study prior to having bariatric surgery
  • Are able to come to the laboratory for testing.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682058
AAAO1655, R01DK072507
Yes
Undecided
Not Provided
Dympna Gallagher, Columbia University
Columbia University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Pittsburgh
Study Director: James Delany, PhD University of Pittsburgh
Columbia University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP