Healthsnap on Epicardial Adipose Tissue Study (HEATS)

University of Miami

Status: Completed

Conditions: Obesity; Pre Diabetes

Treatments: Behavioral: dietary counseling; Behavioral: HealthSnap

Study type: Interventional

Funder types: Other

Identifiers

NCT03683888

20171094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Healthsnap

Experimental group

Description:

50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study

Treatment:

Behavioral: HealthSnap

Diet

Active Comparator group

Description:

50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study

Treatment:

Behavioral: dietary counseling