N/A
N=29
Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
Overweight and Obesity · PreDiabetes · Type 2 Diabetes · Cardiovascular Risk Factor
Bottom Line
View on ClinicalTrials.gov: NCT04763772 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in BMI — 0.43; 0; 4.4; 0 kg/m2 — p=0.2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Body Fat Distribution Imaging Report (Diagnostic_test); Basic Weight Information (Diagnostic_test); Patient Provided (Behavioral); Physician Provided (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BMI |
0.43; 0; 4.4; 0 | 0.2 |
Summary
The overall goal is to determine the real-world feasibility and utility of body fat imaging using rapid MRI to enhance risk perception, induce behavioral change, and improve clinical outcomes in overweight and obese individuals. Here, the investigators will perform a pragmatic clinical effectiveness pilot trial using a 2x2 factorial design to test the hypothesis that provision of a detailed individualized visual report of body fat distribution directly to patients will translate into changes in patient risk perception, behavior, and improved clinical outcomes.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 35 years
- Able to provide informed consent
- Overweight or Obese (BMI ≥25 kg/m2)
- 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
- 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 ( 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
- Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial or plan to initiate therapy during the trial.
- Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 1 month prior to screening for this trial.
- 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).
- Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
- Language barrier, mental incapacity, unwillingness or inability to understand.
- 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.
- Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
- ≥2 no-shows to recruitment clinic within the 6 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT04763772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.