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Body Fat Distribution Imaging for Obesity (BODY-REAL Trial)

N/A
Waitlist Available
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Coronary artery disease (clinical diagnosis)
Low HDL-cholesterol (<40 mg/dL in men and <50 mg/dL in women)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

BODY-REAL Trial Summary

This trial will test whether providing people with a detailed MRI report of their body fat distribution will help them make healthier choices and improve clinical outcomes.

Who is the study for?
This trial is for overweight or obese adults with a BMI of at least 25, who may also have atrial fibrillation, low HDL cholesterol, high triglycerides, sleep apnea, coronary artery disease, congestive heart failure or additional cardiovascular risks. Participants must be over 35 years old and not on anti-obesity drugs recently.Check my eligibility
What is being tested?
The study tests if providing patients with detailed visual reports of their body fat distribution using MRI can change how they see their health risks and lead to better lifestyle choices and clinical outcomes. It's a real-world pilot trial with two different approaches being compared.See study design
What are the potential side effects?
Since the interventions involve receiving information from imaging reports or basic weight data without direct medical treatments, there are no expected side effects related to typical drug trials.

BODY-REAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with coronary artery disease.
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My HDL cholesterol is low.
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I have prediabetes or Type 2 Diabetes.
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My BMI is 25 or higher, indicating I am overweight or obese.
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I have been diagnosed with atrial fibrillation.
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My triglyceride levels are high or I am being treated for high triglycerides.
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I am 35 years old or older.
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I have high blood pressure or am on medication for it.
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I am taking medication for type 2 diabetes.
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I have been diagnosed with obstructive sleep apnea.
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I have been diagnosed with congestive heart failure.

BODY-REAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool.
Blood pressure
Body mass index
+8 more

BODY-REAL Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Patient ProvidedExperimental Treatment1 Intervention
Report provided directly to the patient.
Group II: Detailed ReportExperimental Treatment1 Intervention
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.
Group III: Basic Weight InformationPlacebo Group1 Intervention
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.
Group IV: Physician ProvidedPlacebo Group1 Intervention
Report provided directly to the provider to translate/counsel the patient.

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,325 Total Patients Enrolled

Media Library

Body Fat Distribution Imaging Report Clinical Trial Eligibility Overview. Trial Name: NCT04763772 — N/A
Type 2 Diabetes Research Study Groups: Patient Provided, Detailed Report, Basic Weight Information, Physician Provided
Type 2 Diabetes Clinical Trial 2023: Body Fat Distribution Imaging Report Highlights & Side Effects. Trial Name: NCT04763772 — N/A
Body Fat Distribution Imaging Report 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies to join this trial at present?

"Indeed, the data posted on clinicaltrials.gov indicates that this medical trial is presently accepting new patients. The study was first published on November 1st 2021 and has been recently updated April 7th 2022. A total of 140 individuals are needed to be recruited from one site."

Answered by AI

To what extent is enrollment progressing for this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was published on November 1st 2021, is presently enrolling subjects. They are hoping to recruit 140 people from a single medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~4 spots leftby Aug 2024