Metabolic Syndrome Feasibility Study

NCT02287766 | Completed DMC

• 1 other identifier: EPIC-009
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 2

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 trends consistent with Metabolic Syndrome identified by medical doctors.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Epic Research & Diagnostics, Inc.: lead

Study Sites (2)

EPIC Research and Diagnostics

Scottsdale, Arizona, 85255, United States

Location

Integrated Health Institute, LLC

Scottsdale, Arizona, 85255, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nancy R Rizzo, PhD

  EPIC Research and Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 11, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

US (2)