Metabolic Syndrome Feasibility Study



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - 85
Updated:10/14/2017
Start Date:November 2014
End Date:August 2015

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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.


Metabolic Group

Inclusion Criteria:

1. Sex: Male or Female

2. Age range: 21 to 85

3. 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)

- 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

4. The patient or legal representative is able to understand and provide signed consent
for the procedure.

Exclusion Criteria:

1. Patients < 21years in age or > 85 years in age.

2. Inability or unwillingness to provide informed consent.

3. Patients with pacemakers or another electrical device implanted somewhere in their
body.

4. Pregnant women.

5. Missing all or part of fingers or cuts/burns on pads of fingers

6. Hand tremors or involuntary oscillations of the hands that prevents clear imaging

Control Group:

Inclusion Criteria:

1. Sex: Male or Female

2. Age range: 21 to 85

3. Freedom from qualifying medical diagnoses (control group)

Any one of the following will exclude the subject from participation in the study

1. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)

2. Documented current diagnosis/treatment of coronary artery disease or heart attack

3. Documented as currently in Renal Failure (chronic or acute) or on renal dialysis

4. Documented current diagnosis/treatment for Hepatitis

5 .The patient or legal representative is able to understand and provide signed consent for
the procedure.

Exclusion Criteria:

1. Patients < 21 years in age or > 85 years in age.

2. bility or unwillingness to provide informed consent.

3. Patients with pacemakers or another electrical device implanted somewhere in their
body.

4. Pregnant women.

5. Missing all or part of fingers or cuts/burns on pads of fingers

6. Hand tremors or involuntary oscillations of the hands that prevents clear imaging
We found this trial at
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Scottsdale, Arizona 85255
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Scottsdale, AZ
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Scottsdale, Arizona 85255
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from
Scottsdale, AZ
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