CompletedNot Applicable

Corneal Nerves Function and Structure

United States44 participantsStarted 2021-06-21

Plain-language summary

Peripheral neuropathy affects about 50% of the diabetic population and there is no treatment other than good blood glucose control, which is ineffective in subjects with type 2 diabetes. Part of the problem for the lack of an effective treatment is the inability to detect peripheral neuropathy in its early stage. The hypotheses to be addressed in the first phase of this study is that changes in cornea sensitivity (blinking and squinting) following addition of a hyperosmotic solution will provide a novel screening tool for early diagnosis of peripheral neuropathy. For the second phase of the study the investigators will examine the effect of fish oil treatment of diabetic subjects with neuropathy on corneal nerve density and sensitivity. Corneal nerves are the most highly innervated part of the human body with great sensitivity. The first phase will use this property and determine whether sensitivity is lost in diabetic patients with neuropathy. Preclinical studies have supported this hypothesis and now this will be tested in human subjects. Preclinical studies have also shown that treating diabetic rodents with fish oil improves nerve regeneration and outcome measures of peripheral in diabetic rodents. In the second phase the investigators will perform preliminary studies in human subjects with diabetic neuropathy and determine whether treating them with fish oil increases corneal nerve density and sensitivity.

Who can participate

Age range

50 Years – 75 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 populati…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cornea Sensitivity

Timeframe: Examination of the response to saline and Muro 128 is preformed once in each patient immediately following their consent or if they request at a later more convenient time.

Trial details

NCT IDNCT04222660

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-06-05

Results submitted2024-04-25

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials