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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of ClearView Scan versus Active Diagnosis | Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit |
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Metabolic Group
Inclusion Criteria:
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.
Exclusion Criteria:
Control Group:
Inclusion Criteria:
Any one of the following will exclude the subject from participation in the study
5 .The patient or legal representative is able to understand and provide signed consent for the procedure.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nancy R Rizzo, PhD | EPIC Research and Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPIC Research and Diagnostics | Scottsdale | Arizona | 85255 | United States | ||
| Integrated Health Institute, LLC |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2015 | |
| Reset | Dec 21, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2015 | Dec 21, 2015 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Scottsdale |
| Arizona |
| 85255 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |