Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RX000889-06 | Other Grant/Funding Number | Veterans Adminstration | |
| 5R01DK107399-04 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
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.
Recruitment has been suspended because of the COVID-19 crisis and the Iowa City VA is just beginning to have face to face appointments.
The hypotheses to be studied in the following specific aims is that changes in cornea sensitivity to a hyperosmotic solution will provide a novel screening tool for early diagnosis of diabetic peripheral neuropathy. The investigators also propose that clinical feasibility studies will demonstrate that treatment with fish oil will improve outcome measures of diabetic peripheral neuropathy.
Specific aims:
Determine if the reflex squinting and blinking response to the application of a hyperosmotic solution to the cornea is impaired in patients with type 2 diabetes with or without peripheral neuropathy.
a. Determine whether changes in corneal sensitivity correlate with loss of cornea nerves in the sub-epithelial layer of the cornea and symptom scores for PN.
Determine if treating human subjects with type 2 diabetic peripheral neuropathy with an oral fish oil supplement increases circulating levels of resolvin D1, restores cornea sensitivity to a hyperosmotic eye drop challenge and improves corneal nerve density and symptom scores for peripheral neuropathy.
For this first phase the investigators will enroll 75 subjects to participate (Fifty subjects with type 2 diabetes; 25 with clinically detectable peripheral neuropathy and 25 without neuropathy will be enrolled as well as 25 age-matched control subjects). In the second phase of the study the investigators will investigate whether increased intake of fish oil improves diabetic peripheral neuropathy. Subjects will receive 4g (2g twice a day) of fish oil per day in capsule form.
The investigators first introduced fish oil as a successful treatment of peripheral neuropathy in pre-clinical studies with diabetic rodents and will now expand those studies , culminating in this feasibility study of treatment using human subjects with type 2 diabetes and neuropathy. In this study non diabetic subjects (control) and subjects with type 2 diabetes with mild to moderate peripheral neuropathy will be recruited from phase 1 of this study to participate in the phase 2 treatment phase of the study. A baseline determination of their neuropathy (Subjective Peripheral Neuropathy Screen Questionnaire) including evaluation of corneal nerve structure and sensitivity and blood sample will be performed. Tests besides the questionnaire to be used to screen the subjects for peripheral neuropathy will include 10 g mono filament, vibration threshold, ankle reflex and sensitivity to warm and cold stimulus. Subjects will then be instructed to take 2 fish oil capsules twice a day. Subjects will return at 4, 8 and 12 months for re-evaluation. If successful, the feasibility study will provide a proof of concept to advance fish oils to a larger clinical trial for diabetic peripheral neuropathy.
Visual acuity (subject's vision) will be measured by having the subject read the smallest letters on an eye chart with their glasses or best correction. This takes about 5 minutes or less.
Slit lamp examination: A standard slit lamp examination will be performed to insure that no exclusion criteria are present and no corneal abrasion is present.
The corneal sensitivity procedure will consist of applying a drop of 5% Muro 128 to the eye and recording the blinking and squinting response over the next 5 minutes. Based on preclinical studies it is anticipated that normal subjects will have an increased blinking and squinting response seconds after the addition of the hyperosmotic solution (5% Muro 128), whereas diabetic subjects with neuropathy will have a attenuated response.
Corneal sensation threshold: Corneal sensation will also be measured in each eye using a handheld Luneau Cochet -Bonnet aesthesiometer. This device contains a thin, retractable, nylon monofilament in which the length (stiffness) is varied between 6.0 mm and 1.0 mm until the subject can detect the touch on their central cornea, resulting in a blink reflex. In each eye, testing will begin with the 6.0 mm filament, after which the length will be progressively shortened by 0.5 mm until the patient reports sensing the corneal contact. Each eye will be tested three times and the best performance (in terms of longest filament that is perceived to touch the cornea) will be recorded as the corneal sensation threshold.
Ocular Coherence Tomography (OCT):
The thickness of the optic nerve and macula will also be measured inside of the eye using a special camera that forms an image of the layers of the retina. The imaging is harmless and measures the thickness or structural health of retinal layers and optic nerve. A new feature of OCT is eye-tracking. Eye tracking does not take any longer since it is done simultaneously with the imaging. Eye tracking during OCT may give us new insight into some eye disorders. This test takes approximately 10 minutes.
A hand-held pupillometer/electroretinogram device (RETeval, LKC) will be held in front of the subject s eye, but will not touch the eye. The device will provide a brief, a series of brief light stimuli and then record the pupil response and the elicited electrical response from the retina from a surface skin patch (electrode) placed below each eye, from the light as a measure of whether the inherent sensitivity of the eye in the retina is normal. The investigators will repeat this in the left eye. The visible light stimulus is safe and is given at an intensity experienced in normal daily light exposures. The test takes about 2 minutes per eye.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes without neuropathy | Experimental | Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. |
|
| Type 2 diabetes with neuropathy | Experimental | Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. |
|
| Normal subjects, aged match with no symptoms of diabetes | Experimental | Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blackmores Omega Daily (4 1g capsules per day) | Dietary Supplement | Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. |
| Measure | Description | Time Frame |
|---|---|---|
| Cornea Sensitivity | 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 time the eyelids are closed vs. open over the 150 second period of the recording. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corneal Sensation Threshold Using Cochet Bonnet Filament | This test records the mechanical sensitivity of the cornea to a filament that is touched to the cornea. The rigidity of the filament can be adjusted and the outcome is the length of the filament (6 to 1 cm) when the subjects blinks. The data will be recorded as cm. | Done once to determine whether there is a difference between control and diabetes subjects with peripheral neuropathy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark A Yorek, PhD | Iowa City VA Health Care System, Iowa City, IA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa | 52246-2292 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
The reviewer is correct. Due to the pandemic the course of this study was dramatically changed. Initially there was going to be 2 separate protocols the first to measure cornea sensitivity using a hyperosmotic solution in 3 groups control, and diabetes with or without neuropathy. The second protocol was to be treatment with fish oil to determine whether improvement occurs. Because of COVID we were able to complete only protocol 1 and it was done in only control and diabetes neuropathy subjects.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Type 2 Diabetes With Neuropathy | Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. |
| FG001 | Normal Subjects, Aged Match With no Symptoms of Diabetes | Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Type 2 Diabetes With Neuropathy | Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. |
| BG001 | Normal Subjects, Aged Match With no Symptoms of Diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cornea Sensitivity | 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 time the eyelids are closed vs. open over the 150 second period of the recording. | primary outcome | Posted | Mean | Standard Deviation | time ratio of eyelids closed vs. open | 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. |
|
The procedure for each subject lasted a total of no more than 2 hours. None of the procedures were invasive and had very low risks. The subject was monitored during the procedures.
The only possible adverse event would have been eye discomfort due to the Muro 128 solution. However, after this procedure the subjects eyes were flushed with warm saline. The total time each participant took to complete the study was 2 hours. For this reason all-cause mortality was not monitored.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 2 Diabetes With Neuropathy | Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. |
Not provided
Not provided
Study weaknesses include the number of subjects enrolled being primarily male. The control group was not well age matched. Recruitment of diabetes subjects was restricted to those with known peripheral neuropathy. Additional studies are needed that include diabetes subjects without peripheral neuropathy and those with mild peripheral neuropathy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Yorek | Iowa City VA Healthcare System | 13193380581 | 637696 | mark.yorek@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2024 | Jun 6, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
Not provided
Not provided
The study will be done in two phases. In the second phase the investigators will investigate whether increased intake of fish oil improves diabetic peripheral neuropathy including improvement in corneal nerve morphology and sensitivity. Subjects will receive 4g (2g twice a day) of fish oil per day in capsule form. The second phase of the study will be done in 2 of the 3 groups. The two groups for this phase of the study will be the control subjects and the diabetic subjects with neuropathy.
Not provided
Not provided
Not provided
Not provided
|
|
| Michigan Neuropathy Screening Instrument | All subjects will answer a 15 question survey that relates to symptoms of peripheral neuropathy. The score range is 0-13 with the higher score indicating poorer outcome or increased peripheral neuropathy. | Done once as part of the determination to the subjects peripheral neuropathy. |
| Sensitivity to 10 g Monofilament Test | The 10 g monofilament test is a routine evaluation used to screen the diabetic foot for loss of sensory sensation and part of the standard of care for any diabetic patient. The subject will remove their footwear and lie down on a table. The filament will be applied perpendicular to the skin surface on the bottom of the feet will sufficient force to allow the filament to bend. This is repeated 5 times. Each subject will be asked to tell the examiner if they feel it. The scale is 0 to 1. If the subject feels the monofilament the value each time the score given is 0. If there is no feeling the value is 1. For reduced sensitivity, for example feels the monofilament 2 or 3 times during the test the score is 0.5. A higher score is evidence of peripheral neuropathy. | Done once as a determination of the presence of peripheral neuropathy |
| Presence of Vibratory Sensation of the Great Toe | Vibratory sensation is a standard of care test used with patients with diabetes to test sensory nerve sensation. A 128 Hz tuning fork is used and placed over the dorsum of the great toe on the boney prominence of the distal interphalangeal joint. The subject is asked to tell the examiner if they feel the object touching their toe. This is repeated 3 times. The scale is 0 to 1. If the subject feels the object the score given is 0. If the subject fails to feel the object all 3 times the score is 1. If they feel it once or twice during the examination the score given is 0.5. A higher score is evidence of peripheral neuropathy. | Done once as a determination of the presence of peripheral neuropathy |
| Presence of Reflex | Reflex testing is commonly used to detect sensory neuropathy in diabetic patients. The ankle reflex is examined by aligning the subjects ankle into a neutral position and the examiner strikes the Achilles tendon with a neurological hammer. An abnormal result is recorded if the subject does not display any ankle plantarflexion. The scale is 0 to 1. If the reflex is present the score given is 0. If no reflex is present the score given is 1. If the response is reduced the score given is 0.5. A higher score is evidence of peripheral neuropathy. | Done once as a determination of the presence of peripheral neuropathy |
| Visual Acuity | A routine visual acuity eye examination will be performed. Subjects vision will be measured by having the subject read the smallest letters on an eye chart with their glasses or best correction. Visual acuity (VA) is a measure of the ability of the eye to distinguish shapes and the details of objects at a given distance (20 feet). A person with "normal vision" scores 20/20 as did all our controls. A person with 20/40 vision sees things at 20 feet that most people who don't need vision correction can see at 40 feet. Our subjects with diabetic neuropathy mean score was 20/25. The first number in the score is the number of feet for the test and this is commonly 20 feet. The second number is their visualization of the letters on the eye chart. The investigators used the mean of the second number for analysis. This takes about 5 minutes or less. | Done once to determine the subjects visual ability |
| Questionnaires for Corneal Sensitivity | Ocular Surface Disease Index (OSDI contains 12 questions relating to eye sensitivity to light, vision acuity, dryness, sensitivity when reading, using the computer, and watching TV). The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. | Done once to determine extent of common eye disease such as dry eye |
| Determination of Tibial Nerve Conduction Velocity | This is a non-invasive method of determining conduction velocity of the tibial nerve. the scale is meters per second or m/s. The subject will be instructed to lie down on a examination table with shoes and socks removed. Afterwards, the lower ankle will be swabbed with an alcohol patch and allowed to air dry. A device containing 2 posts (about 3 inches apart) will be placed on the lower ankle in the region of the Achilles and activated. For a period of 5-10 sec the device sends a pulse stimulating the nerve distally (post located at the lower part of the ankle) and the response recorded by the post located distally on the skin of the upper part of the ankle. The nerve conduction is recorded electronically by the device and data down loaded to a secured computer. During the time of the analyses the subject will feel dual pulsating sensation that will last up to 10 sec. | Done once as a determination of the presence of peripheral neuropathy |
Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| cornea sensitivity using isotonic solution | Mean | Standard Deviation | time ratio eyelids closed vs. open |
|
| cornea sensitivity using Cochet-Bonnet | Mean | Standard Deviation | cm |
|
| nerve conduction | Mean | Standard Deviation | m/s |
|
| nerve amplitude | Mean | Standard Deviation | uV |
|
| Dry eye (DEQ 5) questionnaire | The minimum is 0 (healthy) to 22 (extremely poor) | Mean | Standard Deviation | units on a scale |
|
| Ocular Surface Disease Index (OSDI) questionnaire | Based on their OSDI scores, patients can be categorized as having a normal ocular surface (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) ocular surface disease. Full scale is 0 - 100. | Mean | Standard Deviation | units on a scale |
|
| Michigan neuropathy screening instrument | The scale for this test ranges from 0 (healthy) to 13 (poor). A value above 4 indicates presence of peripheral neuropathy. | Mean | Standard Deviation | units on a scale |
|
Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation.
Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid.
| OG001 | Normal Subjects, Aged Match With no Symptoms of Diabetes | Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. |
|
|
|
| Secondary | Change in Corneal Sensation Threshold Using Cochet Bonnet Filament | This test records the mechanical sensitivity of the cornea to a filament that is touched to the cornea. The rigidity of the filament can be adjusted and the outcome is the length of the filament (6 to 1 cm) when the subjects blinks. The data will be recorded as cm. | Posted | Mean | Standard Error | cm | Done once to determine whether there is a difference between control and diabetes subjects with peripheral neuropathy |
|
|
|
|
| Secondary | Michigan Neuropathy Screening Instrument | All subjects will answer a 15 question survey that relates to symptoms of peripheral neuropathy. The score range is 0-13 with the higher score indicating poorer outcome or increased peripheral neuropathy. | Posted | Mean | Standard Error | units on a scale | Done once as part of the determination to the subjects peripheral neuropathy. |
|
|
|
|
| Secondary | Sensitivity to 10 g Monofilament Test | The 10 g monofilament test is a routine evaluation used to screen the diabetic foot for loss of sensory sensation and part of the standard of care for any diabetic patient. The subject will remove their footwear and lie down on a table. The filament will be applied perpendicular to the skin surface on the bottom of the feet will sufficient force to allow the filament to bend. This is repeated 5 times. Each subject will be asked to tell the examiner if they feel it. The scale is 0 to 1. If the subject feels the monofilament the value each time the score given is 0. If there is no feeling the value is 1. For reduced sensitivity, for example feels the monofilament 2 or 3 times during the test the score is 0.5. A higher score is evidence of peripheral neuropathy. | Posted | Mean | Standard Error | units on a scale | Done once as a determination of the presence of peripheral neuropathy |
|
|
|
|
| Secondary | Presence of Vibratory Sensation of the Great Toe | Vibratory sensation is a standard of care test used with patients with diabetes to test sensory nerve sensation. A 128 Hz tuning fork is used and placed over the dorsum of the great toe on the boney prominence of the distal interphalangeal joint. The subject is asked to tell the examiner if they feel the object touching their toe. This is repeated 3 times. The scale is 0 to 1. If the subject feels the object the score given is 0. If the subject fails to feel the object all 3 times the score is 1. If they feel it once or twice during the examination the score given is 0.5. A higher score is evidence of peripheral neuropathy. | Posted | Mean | Standard Error | units on a scale | Done once as a determination of the presence of peripheral neuropathy |
|
|
|
|
| Secondary | Presence of Reflex | Reflex testing is commonly used to detect sensory neuropathy in diabetic patients. The ankle reflex is examined by aligning the subjects ankle into a neutral position and the examiner strikes the Achilles tendon with a neurological hammer. An abnormal result is recorded if the subject does not display any ankle plantarflexion. The scale is 0 to 1. If the reflex is present the score given is 0. If no reflex is present the score given is 1. If the response is reduced the score given is 0.5. A higher score is evidence of peripheral neuropathy. | Posted | Mean | Standard Error | units on a scale | Done once as a determination of the presence of peripheral neuropathy |
|
|
|
|
| Secondary | Visual Acuity | A routine visual acuity eye examination will be performed. Subjects vision will be measured by having the subject read the smallest letters on an eye chart with their glasses or best correction. Visual acuity (VA) is a measure of the ability of the eye to distinguish shapes and the details of objects at a given distance (20 feet). A person with "normal vision" scores 20/20 as did all our controls. A person with 20/40 vision sees things at 20 feet that most people who don't need vision correction can see at 40 feet. Our subjects with diabetic neuropathy mean score was 20/25. The first number in the score is the number of feet for the test and this is commonly 20 feet. The second number is their visualization of the letters on the eye chart. The investigators used the mean of the second number for analysis. This takes about 5 minutes or less. | Posted | Mean | Standard Error | units on a scale | Done once to determine the subjects visual ability |
|
|
|
|
| Secondary | Questionnaires for Corneal Sensitivity | Ocular Surface Disease Index (OSDI contains 12 questions relating to eye sensitivity to light, vision acuity, dryness, sensitivity when reading, using the computer, and watching TV). The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. | Posted | Mean | Standard Error | units on a scale | Done once to determine extent of common eye disease such as dry eye |
|
|
|
|
| Secondary | Determination of Tibial Nerve Conduction Velocity | This is a non-invasive method of determining conduction velocity of the tibial nerve. the scale is meters per second or m/s. The subject will be instructed to lie down on a examination table with shoes and socks removed. Afterwards, the lower ankle will be swabbed with an alcohol patch and allowed to air dry. A device containing 2 posts (about 3 inches apart) will be placed on the lower ankle in the region of the Achilles and activated. For a period of 5-10 sec the device sends a pulse stimulating the nerve distally (post located at the lower part of the ankle) and the response recorded by the post located distally on the skin of the upper part of the ankle. The nerve conduction is recorded electronically by the device and data down loaded to a secured computer. During the time of the analyses the subject will feel dual pulsating sensation that will last up to 10 sec. | Posted | Mean | Standard Error | m/s | Done once as a determination of the presence of peripheral neuropathy |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Normal Subjects, Aged Match With no Symptoms of Diabetes | Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation. Blackmores Omega Daily (4 1g capsules per day): Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid. | 0 | 0 | 0 | 16 | 0 | 28 |
Not provided
Not provided
Not provided
| D005128 | Eye Diseases |