N/A
N=44
Corneal Nerves Function and Structure
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT04222660 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Cornea Sensitivity — 0.177; 0.293 time ratio of eyelids closed vs. open — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blackmores Omega Daily (4 1g capsules per day) (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cornea Sensitivity |
0.177; 0.293 | <0.001 sig |
| SECONDARY Change in Corneal Sensation Threshold Using Cochet Bonnet Filament |
5.683; 5.953 | <0.0025 sig |
| SECONDARY Michigan Neuropathy Screening Instrument |
5.720; 0.5455 | <0.0001 sig |
| SECONDARY Sensitivity to 10 g Monofilament Test |
0.5577; 0.000 | <0.0001 sig |
| SECONDARY Presence of Vibratory Sensation of the Great Toe |
0.6731; 0.000 | <0.0001 sig |
| SECONDARY Presence of Reflex |
0.8125; 0.000 | <0.0001 sig |
| SECONDARY Visual Acuity |
25; 20 | <0.01 sig |
| SECONDARY Questionnaires for Corneal Sensitivity |
11.36; 1.09 | <0.0017 sig |
| SECONDARY Determination of Tibial Nerve Conduction Velocity |
35.60; 50.50 | <0.0195 sig |
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.
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 100 mg/100ml, HDL 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.)
Data sourced from ClinicalTrials.gov (NCT04222660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.