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Completed

NCT Number: NCT03683888

Healthsnap on Epicardial Adipose Tissue Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HealthSnap

Behavioral

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

Behavioral

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

Primary outcomes

  1. Epicardial fat thickness (EAT)

    Time frame: 3 months

    Change in ultrasound measured EAT

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: 3 months

    Change in BMI

  2. Hemoglobin A1c (HbA1c) percentage (%)

    Time frame: 3 months

    Change in the HbA1c %

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: HEATS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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