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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03683888
Other study ID # 20171094
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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