Clinical trial NCT00682058: Body Composition & REE Responses to Bariatric Surgery
Official title: Body Composition & REE Responses to Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Weight Change
Keywords: body composition
weight loss
fat
fat distribution
fat free mass
organ
resting energy expenditure
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Pittsburgh
First posted: 2008-05-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 criteria: * Had to have been enrolled in the ancillary study prior to having bariatric surgery
* Are able to come to the laboratory for testing.

Primary outcomes:
measure: Fat and fat-free mass
timeFrame: Approximately 60 months and 84 months post-bariatric surgery
Secondary outcomes:
measure: Adipose tissue distribution
timeFrame: Approximately 60 months and 84 months post-bariatric surgery
Other outcomes:
measure: Resting energy expenditure
timeFrame: Approximately 60 months and 84 months post-bariatric surgery
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: University of Pittsburgh
name: James Delany, PhD
role: STUDY_DIRECTOR
References:
citation: Ashby-Thompson M, Heshka S, Rizkalla B, Zurlo R, Lemos T, Janumala I, Goodpaster B, DeLany J, Courcoulas A, Strain G, Pomp A, Kang P, Lin S, Thornton J, Gallagher D. Validity of dual-energy x-ray absorptiometry for estimation of visceral adipose tissue and visceral adipose tissue change after surgery-induced weight loss in women with severe obesity. Obesity (Silver Spring). 2022 May;30(5):1057-1065. doi: 10.1002/oby.23415. Epub 2022 Apr 6.