Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02287766
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT02287766
Study Brief:
Protocol Section:
NCT02287766