Status:
COMPLETED
Metabolic Syndrome Feasibility Study
Lead Sponsor:
Epic Research & Diagnostics, Inc.
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21-85 years
Brief 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 t...
Eligibility Criteria
Inclusion
- Metabolic Group
- 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)
- 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.
Exclusion
- 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
- Control Group:
- Inclusion Criteria:
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT02287766
Start Date
November 1 2014
End Date
August 1 2015
Last Update
August 4 2015
Active Locations (2)
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1
EPIC Research and Diagnostics
Scottsdale, Arizona, United States, 85255
2
Integrated Health Institute, LLC
Scottsdale, Arizona, United States, 85255