Clinical trial NCT03683888: Healthsnap on Epicardial Adipose Tissue Study
Official title: Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pre Diabetes
Keywords: epicardial fat
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Epicardial fat thickness (EAT)
timeFrame: 3 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 3 months
measure: Hemoglobin A1c (HbA1c) percentage (%)
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References: