Body Composition & REE Responses to Bariatric Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Pittsburgh
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00682058
First received: May 20, 2008
Last updated: March 28, 2014
Last verified: March 2014

May 20, 2008
March 28, 2014
October 2006
June 2016   (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

This is a continuing renewal application to follow this cohort at 5 to 7 years post-surgery. Important unanswered questions surround the long-term nature of body composition and resting energy expenditure (REE) after substantial and sustained weight loss by severely obese persons. This ancillary study cohort from LABS has been uniquely and comprehensively characterized for body composition and REE at T0 (before surgery), T12 (12 months post-surgery), and T24 (24 months post-surgery); therefore, it is well suited for further study of these same questions at ~T60 and T84 in that: they underwent massive weight loss; the weight loss was sustained at 24 months and is likely to be sustained over a long period of time thereby allowing for an investigation of whether adaptations of organ/tissue mass and fat redistribution occur; and REE relative to FFM at T24 continues to be lower compared to pre-surgery levels which is largely due to ongoing changes in organ mass. We propose to examine body composition and REE at the organ-tissue level at two additional time points, 60 months (T60) and 84 months (T84) post-surgery. We will continue to analyze the composition of body weight using the same advanced body composition models and measurement methods. 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).

Consenting, eligible LABS patients previously enrolled in this ancillary study from Weill Cornell and the University of Pittsburgh will undergo the following measures: total body water by deuterium dilution (fat and FFM), extracellular water by sodium bromide tracer, body density by the BodPod, whole-body MRI (adipose tissue and its distribution; skeletal muscle mass; mass of liver, kidneys, heart, and brain), dual energy-X-ray absorptiometry (femur BMD, total body fat, fat-free mass, and bone mineral content), and REE. Subjects will be a 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

Consenting, eligible LABS patients from Weill Cornell and the University of Pittsburgh, prior to bariatric surgery

  • Obesity Surgery
  • Weight Loss Composition
Procedure: Surgery
Follow-up of those subjects who had bariatric surgery (as part of the parent LABS trial) immediately following the collection of baseline measures in this study. Follow-up measures will be acquired at 60 months and 84 months post-baseline measures (post-surgery).
LABS patients
Bariatric surgery patients with 35>BMI kg/m2<60 prior to surgery
Intervention: Procedure: 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
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • males and females
  • 35>BMI kg/m2<60

Exclusion Criteria:

  • claustrophobic
  • abnormal thyroid or cortisol
  • diuretic medication
  • children (<18 years)
  • African-American and Caucasian
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682058
DK72507, R01DK072507, NIH DK72507
Yes
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Pittsburgh
Study Director: James Delany, PhD University of Pittsburgh
St. Luke's-Roosevelt Hospital Center
March 2014

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