Metabolic SyndromeEPIC-009NCT02287766
Metabolic Syndrome Feasibility Study
An observational study of Metabolic Syndrome, run by Epic Research & Diagnostics, Inc. at 2 sites in United States.
Trial summary
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with Metabolic Syndrome identified by medical doctors. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 193 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Aug 2015
- Phase
- Observational
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women ages 21-85 who present to the investigators clinical office and meet all of the inclusion criteria while having none of the exclusion criteria will be approached for consent to participate in the study.
Who may be able to join
- Sex: Male or Female
- Age range: 21 to 85
- Qualifying Metabolic Syndrome diagnosis(using the National Cholesterol Education Program Adult Treatment Panel (ATP) III definition)(Grundy, 2004)
- Subjects will be identified as having Metabolic Syndrome if they meet at least three of the following five criteria:
- Elevated waist circumference: ≥ 102 cm (≥40 inches) in men, ≥ 88 cm (≥35 inches) in women
- Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L) or on drug treatment for elevated triglycerides (examples include, but are not limited to, fibrates and nicotinic acid)
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- Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in men or < 50 mg/dL (1.3 mmol/L) in women or on drug treatment for reduced HDL-C
- Elevated blood pressure: ≥ 130 mm Hg systolic blood pressure or ≥85 mm Hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension
- Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated glucose
- The patient or legal representative is able to understand and provide signed consent for the procedure.
- Sex: Male or Female
- Age range: 21 to 85
- Freedom from qualifying medical diagnoses (control group)
- Any one of the following will exclude the subject from participation in the study
- Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
- Documented current diagnosis/treatment of coronary artery disease or heart attack
- Documented as currently in Renal Failure (chronic or acute) or on renal dialysis
- Documented current diagnosis/treatment for Hepatitis
- 5 .The patient or legal representative is able to understand and provide signed consent for the procedure.
Who cannot join
- Patients < 21years in age or > 85 years in age.
- Inability or unwillingness to provide informed consent.
- Patients with pacemakers or another electrical device implanted somewhere in their body.
- Pregnant women.
- Missing all or part of fingers or cuts/burns on pads of fingers
- Hand tremors or involuntary oscillations of the hands that prevents clear imaging
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- Control Group:
- Patients < 21 years in age or > 85 years in age.
- bility or unwillingness to provide informed consent.
- Patients with pacemakers or another electrical device implanted somewhere in their body.
- Pregnant women.
- Missing all or part of fingers or cuts/burns on pads of fingers
- Hand tremors or involuntary oscillations of the hands that prevents clear imaging
Trial locations and contacts
2 sites in 1 country.
United States2 sites
EPIC Research and Diagnostics
Scottsdale, Arizona, 85255
Integrated Health Institute, LLC
Scottsdale, Arizona, 85255
About this study
Official title: Prognostic Indicators for Metabolic Syndrome as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with Metabolic Syndrome identified by medical doctors.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Men and women ages 21-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following cancer, coronary artery disease or heart attack, renal failure or dialysis, hepatitis, Multiple Sclerosis, or any autoimmune disorder. | |
| Metabolic Syndrome Diagnosis Group | Men and women ages 21-85 with at least of at least three of the following (as defined in the protocol) : Elevated waist circumference, elevated triglycerides, reduced HDL cholesterol, elevated blood pressure, elevated fasting glucose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of ClearView Scan versus Active Diagnosis
The EPIC ClearView software produces a Response Scale report that summarizes the electrophysiological measurements associated with organ systems. The autonomic numbers indicate how the person's stress response is affecting different body systems and the physical numbers reflect physiological function.These measurements will then be compared to metabolic diagnosis.
Measured: At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit
Secondary outcomes (1)
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
Measured: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epic Research & Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy R Rizzo, PhD, Principal investigator, EPIC Research and Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287766
- Sponsor's protocol ID
- EPIC-009
- Acronym
- EPIC-009
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Indicators for Metabolic Syndrome as Provided by the EPIC ClearView
- ClinicalTrials.gov ID
- NCT02287766
- Acronym / sponsor ID
- EPIC-009 / EPIC-009
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Epic Research & Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Nov 2014 (estimated)
- 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 objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with Metabolic Syndrome identified by medical doctors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Men and women ages 21-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following cancer, coronary artery disease or heart attack, renal failure or dialysis, hepatitis, Multiple Sclerosis, or any autoimmune disorder. |
| Metabolic Syndrome Diagnosis Group | – | –Men and women ages 21-85 with at least of at least three of the following (as defined in the protocol) : Elevated waist circumference, elevated triglycerides, reduced HDL cholesterol, elevated blood pressure, elevated fasting glucose. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women ages 21-85 who present to the investigators clinical office and meet all of the inclusion criteria while having none of the exclusion criteria will be approached for consent to participate in the study.
Key inclusion criteria (19 listed)
- Sex: Male or Female
- Age range: 21 to 85
- Qualifying Metabolic Syndrome diagnosis(using the National Cholesterol Education Program Adult Treatment Panel (ATP) III definition)(Grundy, 2004)
- Subjects will be identified as having Metabolic Syndrome if they meet at least three of the following five criteria:
- The patient or legal representative is able to understand and provide signed consent for the procedure.
Key exclusion criteria (13 listed)
- Patients < 21years in age or > 85 years in age.
- Inability or unwillingness to provide informed consent.
- Patients with pacemakers or another electrical device implanted somewhere in their body.
- Pregnant women.
- Missing all or part of fingers or cuts/burns on pads of fingers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement of ClearView Scan versus Active Diagnosis
Time frame: At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit
The EPIC ClearView software produces a Response Scale report that summarizes the electrophysiological measurements associated with organ systems. The autonomic numbers indicate how the person's stress response is affecting different body systems and the physical numbers reflect physiological function.These measurements will then be compared to metabolic diagnosis.
1 secondary outcome
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
Time frame: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit
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 4 Aug 2015.
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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.
Nancy R Rizzo, PhD principal investigator
EPIC Research and Diagnostics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Epic Research & Diagnostics, Inc. at 2 sites 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 19 inclusion and 13 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Agreement of ClearView Scan versus Active Diagnosis (time frame: At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit). 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 4 Aug 2015.