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
  Purpose

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).


Condition Intervention
Obesity Surgery
Weight Loss Composition
Procedure: 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 St. Luke's-Roosevelt Hospital Center:

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: June 2016
Estimated Primary Completion Date: June 2016 (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
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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
St. Luke's-Roosevelt Institute for Health Sciences
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
University of Pittsburgh
Investigators
Study Director: James Delany, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00682058     History of Changes
Other Study ID Numbers: DK72507, R01DK072507, NIH DK72507
Study First Received: May 20, 2008
Last Updated: March 28, 2014
Health Authority: United States: Federal Government

Keywords provided by St. Luke's-Roosevelt Hospital Center:
body composition
weight loss
fat
fat distribution
fat free mass
organ
resting energy expenditure

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

ClinicalTrials.gov processed this record on September 29, 2014