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Completed

NCT Number: NCT02287766

Metabolic Syndrome Feasibility Study

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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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EPIC Research and Diagnostics, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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 criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Epic Research & Diagnostics, Inc.

Industry

Registry information

Official study title

Prognostic Indicators for Metabolic Syndrome as Provided by the EPIC ClearView

Acronym: EPIC-009

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2014
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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