Overview

This trial is active, not recruiting.

Conditions weight loss, weight change
Treatment follow-up post-bariatric surgery
Sponsor Columbia University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2006
End date July 2017
Trial size 106 participants
Trial identifier NCT00682058, AAAO1655, R01DK072507

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Bariatric surgery patients with 35>BMI kg/m2<60 prior to surgery will undergo follow-up post-bariatric surgery.
follow-up post-bariatric surgery Observational at this time with no intervention
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).

Primary Outcomes

Measure
Fat and fat-free mass
time frame: Approximately 60 months and 84 months post-bariatric surgery

Secondary Outcomes

Measure
Adipose tissue distribution
time frame: Approximately 60 months and 84 months post-bariatric surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Body Composition & REE Responses to Bariatric Surgery
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Columbia University.