Metabolic Syndrome Feasibility Study

Metabolic Syndrome Clinical Trial

— EPIC-009  

Official title:

Prognostic Indicators for Metabolic Syndrome as Provided by the EPIC ClearView

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287766
• Other study ID #: EPIC-009
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: August 3, 2015
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Epic Research & Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Locations

Country	Name	City	State
United States	EPIC Research and Diagnostics	Scottsdale	Arizona
United States	Integrated Health Institute, LLC	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Epic Research & Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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