ObesityHEATSNCT03683888
Healthsnap on Epicardial Adipose Tissue Study
A study testing HealthSnap and dietary counseling in people with Obesity and Pre Diabetes, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Pre Diabetes
- What is being tested?
- HealthSnap and dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Pre Diabetes
- Being tested
- HealthSnap, dietary counseling
- Keywords
- epicardial fat
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthSnapBehavioural
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 counselingBehavioural
Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant
| Study group | Role | What they receive |
|---|---|---|
| Healthsnap | Experimental | 50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study Receives: Behavioral: HealthSnap |
| Diet | Active comparator | 50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study Receives: Behavioral: dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial fat thickness (EAT)
Change in ultrasound measured EAT
Measured: 3 months
Secondary outcomes (2)
Body Mass Index (BMI)
Change in BMI
Measured: 3 months
Hemoglobin A1c (HbA1c) percentage (%)
Change in the HbA1c %
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jun 2018
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Iacobellis, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683888
- Sponsor's protocol ID
- 20171094
- Acronym
- HEATS
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes
- ClinicalTrials.gov ID
- NCT03683888
- Acronym / sponsor ID
- HEATS / 20171094
- Conditions
- Obesity, Pre Diabetes
- Keywords
- epicardial fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Healthsnap | Experimental | Behavioral: HealthSnap50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study |
| Diet | Active comparator | Behavioral: dietary counseling50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- • Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthSnapHealthSnap 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 | Behavioural | Healthsnap |
| dietary counselingDietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant | Behavioural | Diet |
Primary outcome
Epicardial fat thickness (EAT)
Time frame: 3 months
Change in ultrasound measured EAT
2 secondary outcomes
Body Mass Index (BMI)
Time frame: 3 months
Hemoglobin A1c (HbA1c) percentage (%)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthSnap and dietary counseling in people with Obesity and Pre Diabetes, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial fat thickness (EAT) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.