Healthsnap on Epicardial Adipose Tissue Study

Obesity Clinical Trial

— HEATS  

Official title:

Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683888
• Other study ID #: 20171094
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• Pre Diabetes
• Prediabetic State

Intervention

Behavioral:
• HealthSnap
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
• dietary counseling
Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epicardial fat thickness (EAT)	Change in ultrasound measured EAT	3 months
Secondary	Body Mass Index (BMI)	Change in BMI	3 months
Secondary	Hemoglobin A1c (HbA1c) percentage (%)	Change in the HbA1c %	3 months