Healthsnap on Epicardial Adipose Tissue Study
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2018 |
| Start Date: | June 1, 2018 |
| End Date: | June 1, 2020 |
| Contact: | Gianluca Iacobellis, MD PhD |
| Email: | giacobellis@med.miami.edu |
| Phone: | 3052433636 |
Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes
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.
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.
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.
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.
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
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Gianluca Iacobellis, MD PhD
Phone: 305-243-3636
University of Miami A private research university with more than 15,000 students from around the...
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