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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
  Purpose
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 Intervention
Weight Loss
Weight Change
Other: Follow-up post-bariatric surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body Composition & REE Responses to Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Fat and fat-free mass [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adipose tissue distribution [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Resting energy expenditure [ Time Frame: Approximately 60 months and 84 months post-bariatric surgery ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: October 2006
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Dympna Gallagher, Associate Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00682058     History of Changes
Other Study ID Numbers: AAAO1655  R01DK072507 
Study First Received: May 20, 2008
Last Updated: June 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016