Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
NCT ID: NCT04763772
Last Updated: 2025-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2021-11-01
2024-07-31
Brief Summary
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Detailed Description
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Specific Aim 2: To compare the clinical effectiveness of communicating body fat information to the medical provider (with the intent that the provider interprets the data and translates it to the patient) versus communicating the body fat information directly to the patient. Hypothesis 2: Provision of body fat information directly to the patient will be superior to provision of the information to the provider on risk perception, behavioral change, and clinical outcomes (as assessed in Aim 1).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Detailed Report
A detailed body composition profile report that consists of the following elements: basic demographic data, percent body fat, weight to muscle ratio, visceral fat and abdominal subcutaneous fat volume, visceral fat ratio (the fraction of visceral divided by total abdominal fat), muscle fat infiltration and liver fat (%), and thigh muscle volumes (also separated into right and left, anterior and posterior compartments). Each parameter is presented on a visual scale in the context of the individual value, general population defined by reference data (from United Kingdom (UK) Biobank population), a metabolic disease-free population (also from UK Biobank), low/high and very low/very high, corresponding to 15th and 5th percentiles, respectively. There are also descriptions of each biomarker and how they are derived to provide context for the recipient.
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.
Basic Weight Information
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information
Body weight and body mass index
Patient Provided
Report provided directly to the patient.
Patient Provided
Body weight/fat distribution information will be provided directly to the patient
Physician Provided
Report provided directly to the provider to translate/counsel the patient.
Physician Provided
Body weight/fat distribution information will be provided directly to the physician
Interventions
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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.
Basic Weight Information
Body weight and body mass index
Patient Provided
Body weight/fat distribution information will be provided directly to the patient
Physician Provided
Body weight/fat distribution information will be provided directly to the physician
Eligibility Criteria
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Inclusion Criteria
2. Able to provide informed consent
3. Overweight or Obese (BMI ≥25 kg/m2)
4. Prediabetes or Type 2 Diabetes:
* Fasting glucose \>100 mg/dl, or
* Hb A1c \>5.7%, or
* Medical (i.e. pharmacologic) treatment for type 2 diabetes
5. At least 1 additional cardiovascular risk factor (defined by Adult Treatment Panel III criteria2) including:
* Hypertension (BP\>130/80 or on medical therapy for hypertension)
* Low HDL-cholesterol (\<40 mg/dL in men and \<50 mg/dL in women)
* High triglycerides (\>150 mg/dL or on treatment for hypertriglyceridemia)
* Obstructive sleep apnea (clinical diagnosis)
* Coronary artery disease (clinical diagnosis)
* Congestive heart failure (clinical diagnosis)
* Atrial fibrillation (clinical diagnosis)
Exclusion Criteria
2. Self-reported or clinically documented history of significant fluctuations (\>5% change) in weight within 1 month prior to screening for this trial.
3. Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
4. Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
5. Language barrier, mental incapacity, unwillingness or inability to understand.
6. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.
7. Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
8. ≥2 no-shows to recruitment clinic within the 6 months prior to screening.
35 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Ian J. Neeland, MD
Director, UH Center for Cardiovascular Prevention
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY20201918
Identifier Type: -
Identifier Source: org_study_id
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