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NCT04222660 · ClinicalTrials.gov registry record · NA
Corneal Nerves Function and Structure
A NA study of Diabetic Peripheral Neuropathy, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT04222660: Completed NA study of Diabetic Peripheral Neuropathy, sponsored by VA Office of Research and Development.
NCT04222660 is a NA study of Diabetic Peripheral Neuropathy that has completed, run by VA Office of Research and Development. The registered enrollment target is 44 participants, below the 126-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04222660, a NA study of Diabetic Peripheral Neuropathy, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Cornea sensitivity to a isotonic and hyperosmotic solution is evaluated as the amount of time the eyelid is closed over a period of 150 seconds following application of first isotonic saline (0.9% NaCl) followed by Muro 128 (5% NaCl solution) after a 5 minute recovery/washout period. The evaluation is done from analyzing the recordings of each event using a multi-camera video platform. The results are reported for response to saline (baseline) and Muro (stimulant) solutions as a ratio of the tim
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Blackmores Omega Daily (4 1g capsules per day)
Study Locations (1)
Iowa
- Iowa City VA Health Care System, Iowa City, IA - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2025-05-13 |
| Phase | NA |
What the finished NCT04222660 record still lists
NCT04222660 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 126-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Diabetic Peripheral Neuropathy appearing as the primary indexed condition, and to 1 intervention - of which Blackmores Omega Daily (4 1g capsules per day) is the first listed.
NCT04222660 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT04222660 about?
NCT04222660 is a clinical study titled "Corneal Nerves Function and Structure". 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 it...
What is the current status of trial NCT04222660?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2021-06-21. Estimated completion is 2025-05-13.
What conditions does trial NCT04222660 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy.
What interventions are being tested in trial NCT04222660?
The interventions under investigation include: Blackmores Omega Daily (4 1g capsules per day) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04222660?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04222660 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04222660's enrollment target sits among peer trials
44 12th of 17 higher than 4 of 17 other Diabetic Peripheral Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Peripheral Neuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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