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

Type 2 Diabetes Clinical Trial

— BODY-REAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04763772
• Other study ID #: STUDY20201918
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and values relative to normative data using a visual scale in a population of overweight and obese adults with prediabetes or type 2 diabetes and at least one additional cardiovascular disease risk factor. Hypothesis 1: Provision of a detailed body fat distribution report contextualized with information describing the relevance of each body fat parameter will be superior to provision of body weight/BMI information alone on risk perception, behavioral change (enhanced physical activity, dietary choices, and preventive provider practices and medication adherence), and clinical outcomes (reduction in weight and waist circumference, blood pressure, triglycerides, and glycosylated hemoglobin).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

1. Age = 35 years

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:

1. 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.

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Overweight
• Overweight and Obesity
• PreDiabetes
• Type 2 Diabetes

Intervention

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.
• Basic Weight Information
Body weight and body mass index

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	kilograms	6 months
Primary	Waist circumference	centimeters	6 months
Primary	Blood pressure	mmHg	6 months
Primary	Body mass index	kg/m2	6 months
Primary	Perception of Risk for Diabetes (RPS-DD).	This is a survey questionnaire with responses corresponding to a number. The total score is the sum of all the responses. Min=22, Max=96. Lower scores denote greater perception of risk.	6 months
Primary	Perception of Heart Disease (PRHDS).	This is a survey questionnaire with responses corresponding to a number. The total score is the sum of all the responses. Min=20, Max=80. Higher scores denote greater perception of risk of getting heart disease.	6 months
Primary	Motivation to Change Behaviors (TSRQ).	This is a survey questionnaire with responses corresponding to a number. The total score is the sum of all the responses. Min=50, Max=350. Lower scores denote less treatment self-regulation.	6 months
Primary	Global Physical Activity Questionnaire (GPAQ).	The Global Physical Activity Questionnaire was developed by WHO for physical activity surveillance in countries. It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16). The domains are: Activity at work; Travel to and from places; Recreational activities	6 months
Primary	Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool.	This is a questionnaire regarding dietary intake and behaviors.	6 months
Primary	Medication Adherence (MARS).	This is a questionnaire (yes/no) regarding medication adherence and tolerability.	6 months
Primary	Step counts by Actigraphy.	This is a count of total steps. Total step counts (per day, averaged over 1 week) will be quantified.	6 months