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Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Miami
Miami, Florida, United States
Start Date
June 1, 2018
Primary Completion Date
September 10, 2020
Completion Date
September 10, 2020
Last Updated
September 16, 2020
20
ACTUAL participants
HealthSnap
BEHAVIORAL
dietary counseling
BEHAVIORAL
Lead Sponsor
University of Miami
NCT01143454
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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