Status:
COMPLETED
Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Overweight and Obesity
PreDiabetes
Eligibility:
All Genders
35+ years
Phase:
NA
Brief 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 overw...
Detailed Description
Specific Aim 1: To compare the clinical effectiveness of communicating the body weight and BMI using a visual aid alone versus a detailed body fat distribution report including individualized images a...
Eligibility Criteria
Inclusion
- 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 (\<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
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04763772
Start Date
November 1 2021
End Date
July 31 2024
Last Update
March 25 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106