Healthsnap on Epicardial Adipose Tissue Study (HEATS)
Primary Purpose
Obesity, Pre Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HealthSnap
dietary counseling
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring epicardial fat
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) ≥ 27 kg/m2
- HbA1c 5.7-6.5% within 3 months the initial visit and/or
- Fasting blood glucose (FBG) 100-125 mg/dl within 3 months the initial visit and/or
- Family history for diabetes or CAD or dyslipidemia
Exclusion Criteria:
• Type 1 diabetes
- Pregnancy
- Mental illness preventing correct use of HealthSnap
- Physical inability to follow HealthSnap recommendations
- Active infective and neoplastic diseases
- No current diabetes medications with the exception of Metformin
- Chemotherapy
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Healthsnap
Diet
Arm Description
50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study
50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study
Outcomes
Primary Outcome Measures
Epicardial fat thickness (EAT)
Change in ultrasound measured EAT
Secondary Outcome Measures
Body Mass Index (BMI)
Change in BMI
Hemoglobin A1c (HbA1c) percentage (%)
Change in the HbA1c %
Full Information
NCT ID
NCT03683888
First Posted
September 21, 2018
Last Updated
September 11, 2020
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT03683888
Brief Title
Healthsnap on Epicardial Adipose Tissue Study
Acronym
HEATS
Official Title
Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to learn about the effectiveness of HealthSnap assessment, to reduce epicardial fat thickness. Excessive epicardial fat is associated with higher risk of developing diabetes and heart diseases. HealthSnap Assessment is a simple, quick and not invasive tool that will provide the patient with a personalized information nutritional and exercise plan.The use of HealthSnap in the clinical practice has not been evaluated, yet.
Detailed Description
This study will evaluate the practicality of adding the HealthSnap algorithm to the standard care of patients with overweight/obesity and pre-diabetes.
Participants will be recruited among the outpatient population who routinely refer to the Lennar Foundation Comprehensive Diabetes Center Outpatient Clinics, Division of Endocrinology, Diabetes and Metabolism University of Miami, for standard care and management of diabetes, obesity, overweight, hypertension, dyslipidemia.
Once patient eligibility and written consent are obtained, participant is then scheduled for the clinic visit through the University of Miami UChart (Epic) electronic system. The visits will be coordinated by the research coordinator. At each visit each patient will undergo:
Full physical examination, body weight, height, waist and hip circumference, blood pressure (standard of care)
Fasting blood glucose and haemoglobinA1c (HbA1c), lipid panel, comprehensive metabolic panel, fasting insulin, C-peptide and pro-insulin (all procedures are standard of care)
Ultrasound assesment of epicardial fat, performed on site
HealthSnap assessment performed on site (if randomized to the group receiving additional Healthnap)
Standard of care dietary counselling performed on site by a registered dietitian (if randomized to the control group)
Study patients and controls will be contacted by the dietitian and/or HealthSnap supervisor once a week via telephone, or email (Uchart) or via online session (collaborate Ultra) to monitor their compliance and adherence to the exercise and dietary program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre Diabetes
Keywords
epicardial fat
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthsnap
Arm Type
Experimental
Arm Description
50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study
Arm Title
Diet
Arm Type
Active Comparator
Arm Description
50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study
Intervention Type
Behavioral
Intervention Name(s)
HealthSnap
Intervention Description
HealthSnap provides personalized lifestyle reports and track progress over time using an electronic lifestyle record (ELR). HealthSnap Assessment is a simple, quick and not invasive tool that uses an algorithm that includes a questionnaire, physical measurements, dietary data and body fat indices
Intervention Type
Behavioral
Intervention Name(s)
dietary counseling
Intervention Description
Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant
Primary Outcome Measure Information:
Title
Epicardial fat thickness (EAT)
Description
Change in ultrasound measured EAT
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Change in BMI
Time Frame
3 months
Title
Hemoglobin A1c (HbA1c) percentage (%)
Description
Change in the HbA1c %
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) ≥ 27 kg/m2
HbA1c 5.7-6.5% within 3 months the initial visit and/or
Fasting blood glucose (FBG) 100-125 mg/dl within 3 months the initial visit and/or
Family history for diabetes or CAD or dyslipidemia
Exclusion Criteria:
• Type 1 diabetes
Pregnancy
Mental illness preventing correct use of HealthSnap
Physical inability to follow HealthSnap recommendations
Active infective and neoplastic diseases
No current diabetes medications with the exception of Metformin
Chemotherapy
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Healthsnap on Epicardial Adipose Tissue Study
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