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:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT04222660
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes patients diagnosed based on the opinion of an Endocrinologist (Dr. Correia), the absence of a history of ketoacidosis, and a C-peptide \> 0.8 ng/ml
* At least 5 year known duration of diabetes.
* HbA1c \< 9.0%
* None or mild to moderate peripheral neuropathy based on medical record, Michigan Neuropathy Screening Instrument including response to monofilament test, ankle reflex test, vibration perception threshold examination using a 128 Hz tuning fork as well as hot and cold sensation evaluation
Exclusion Criteria:
* Any neurologic, muscular, genetic, or other condition known to affect nerve or muscle function
* Electrolyte abnormalities, untreated hypothyroidism, abnormalities in calcium, phosphate, or magnesium concentrations, or any other metabolic disturbance affecting neural function
* Cigarette smoking in the past year
* Peripheral vascular, cardiac, pulmonary, or any other disorder affecting blood or tissue oxygenation
* Risk of bleeding disorder or on medication known to increase risk of bleeding
* History for use of aspirin
* Any other medical or psychological condition judged to limit compliance with the protocol or interpretation of results
* History of diabetic foot ulcer
* LDL \> 100 mg/100ml, HDL \< 30 mg/100ml, Triglyceride \> 400 mg/100ml.\* 10) BP \< 140 systolic and 80 diastolic
* BMI 45
* Insulin use to manage diabetes 200 units
* History of taking fish oil supplements
* The investigators are limiting subject population to those over 50 thus pregnancy should not be an issue nonetheless females who are pregnant, looking to become pregnant or are breast feeding will be excluded (\* After overnight fast of 8-12 h; Average of three determinations in the sitting position after at least 5 minutes rest.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04222660
Study Brief:
Protocol Section:
NCT04222660