Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
Overweight and ObesityPreDiabetesType 2 DiabetesCardiovascular Risk Factor
Interventions
DIAGNOSTIC_TEST

Body Fat Distribution Imaging Report

Those randomized to body fat distribution imaging will be scanned on a 1.5 Tesla Siemens Aera MRI scanner (Siemens, Erlangen, Germany), located in the Center for Advanced Heart and Vascular Care using a 6-minute dual-echo Dixon Vibe protocol providing a water and fat separated volumetric data set covering neck to knees, and a multiecho Dixon acquisition for proton density fat fraction assessment in the liver. Images of the liver will be acquired using a 16-channel SENSE extra large Torso coil and images from the rest of the body will be acquired using the body coil. Volumetric imaging datasets of the body derived by MRI will be generated and adipose tissue/fat depots will be quantified: abdominal subcutaneous compartment (ASAT), visceral compartment (VAT), and hips and buttocks (lower body fat); proton density fat fraction of the liver (i.e. hepatic steatosis) as well as the quality of lean (skeletal muscle) including muscle volume and degree of fat infiltration.

DIAGNOSTIC_TEST

Basic Weight Information

Body weight and body mass index

BEHAVIORAL

Patient Provided

Body weight/fat distribution information will be provided directly to the patient

BEHAVIORAL

Physician Provided

Body weight/fat distribution information will be provided directly to the physician

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
lead

University Hospitals Cleveland Medical Center

OTHER

NCT04763772 - Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study | Biotech Hunter | Biotech Hunter