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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug632 | Blackmores Omega Daily (4 1g capsules per day) Wiki | 0.58 |
| drug5025 | lifestyle modification Wiki | 0.58 |
| drug5194 | ricolinostat Wiki | 0.58 |
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There are 3 clinical trials
Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization. Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program. However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants. The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.
Description: This is a cardiac autonomic measure that will be carried out using clinical equipment in the autonomic laboratory at the site. The measurement requires placing electrodes near the heart similar to an EKG.
Measure: Autonomic Function: heart rate variability Time: 12 monthsDescription: This outcome measure assesses changes in trunk positioning using a standardized, validated test.
Measure: balance Time: 6 and 12 monthsDescription: This outcome assesses sweat gland nerve fiber density, which is proposed as a sensitive neuropathy pathology biomarker.
Measure: Sweat gland nerve fiber density Time: 12 monthsThis is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN.
Description: Difference between mean average pain intensity
Measure: Mean Average Pain Intensity (NRS) Time: Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]Description: Difference between mean average pain intensity
Measure: Mean Average Pain Intensity (NRS) Time: Baseline week [Day-7 to Day 1] compared to Week 4Description: Change in non-pain neuropathic signs
Measure: Non-pain Neuropathic Signs (UENS) Time: Baseline week [Day-7 to Day 1] compared to Week 12Peripheral 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.
Description: A recording of the eyes will be performed using a multi-camera video platform for a period of 150 seconds at four different time points. The first will be a baseline, second after a drop of isotonic saline and 3 and 4 after drops of 2 increasing concentrations of Muro 128 (2% sodium chloride, and 5% sodium chloride). Each of these will be separated by a 5 minute rest period. After, this is completed each subject will also be asked to record their sense of pain to each eye drop solution on a scale of 1 to 10. Squinting (an analysis of the amount of time a extent that the eye is closed) and blinking (number of blinks during the procedure) will be quantified during each time point using an image analysis program which analyzes the recorded digital video frames.
Measure: Change in corneal sensitivity to hyperosmotic eye drop Time: Done once as the primary outcome of phase 1 of the study and again at the end of the study after 12 months of fish oil treatment.Description: This is a primary endpoint for phase 2 of the study. Prior to beginning treatment with fish oil and 1 year later after fish oil intervention is complete the subjects cornea nerve density will be determined using cornea confocal microscopy. This is a non-invasive procedure that takes images on the sub-epithelial layer of the cornea. Six images will be collected at each of the two visits. From these images the total corneal nerve length will be determined and reported as mm/mm2
Measure: Change in cornea nerve density Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: 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.
Measure: Change in corneal sensation threshold using Cochet Bonnet filament Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: All subjects will answer a 15 question survey that relates to symptoms of peripheral neuropathy.
Measure: Change in Michigan neuropathy screening instrument Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: Ocular coherence tomography is a special camera that measures the neural structure of the retina. This device is often used as standard of care. The subject will rest their chin on a supporting device and the camera will be positioned to image the neural retina. The test will take about 5 minutes and will be performed twice at baseline and 12 months later.
Measure: Change in ocular coherence tomography. Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: This examination will be the last test performed by each subject enrolled in the study. This device will shine light in the eye to examine the front and back portions of the eye.
Measure: Change in slit lamp examination of the eye. Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: 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. Each subject will be asked to tell the examiner if they feel it. A lack of sensation is a marker for diabetic neuropathy.
Measure: Change in 10 g monofilament test Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: Vibratory sensation is a standard of care test used with patients with diabetes to test sensory nerve sensation. A 129 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. A lack of sensation is a marker for diabetic neuropathy.
Measure: Change in vibratory sensation of the great toe. Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: 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.
Measure: Change in reflex testing Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: Cold and warm thresholds measure response of A-delta and C fibers of sensory nerves. A Velcro strap containing a metal circular pad about the size of a half dollar is attached to the dorsal part of the right foot. The subject is asked to push a button on a hand held device when they feel hot or cold from the circular pad attached to their foot. The device is set to default before any damaging temperature is reached. First warm followed by cold will be tested and the temperature of the pad will be recorded when the patient pushes the button. The commercial TSA-II Neurosensory Analyzer will be used.
Measure: Change in hot or cold sensation. Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: A routine visual acuity eye examination will be used. Subjects 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.
Measure: Change in visual acuity (subject's vision) Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: Blood will be collected at baseline and end of the phase 2 part of the study. Blood will be used to determine the omega-6 to omega-3 ratio in blood a marker of inflammatory stress.
Measure: Change in omega-3 polyunsaturated fatty acids and their metabolites in serum Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: 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.
Measure: Change in pupil responsiveness to light Time: Done once as a baseline measurement for phase 2 of the study and again at the end of the study after 12 months of fish oil treatment.Description: There will be two questionnaires, Ocular Surface Disease Index (OSDI which contains 12 questions eye sensitivity to light, vision acuity, dryness, and sensitivity when reading, using the computer, and watching TV) and the Dry Eye Questionnaire (DEQ which contains 5 questions relating to discomfort, dryness and watery eyes).
Measure: Questionnaires for corneal sensitivity Time: Done once as baseline for phase 1 of the study and also will be repeated at the end of phase 2 of the study.Description: This is a commercial instrument that records the amplitude and latency of the blink reflex to a carefully controlled air puff of CO2 that is directed at the temporal conjunctiva. Each eye is stimulated 3 times and the response recorded using 240 Hz high speed video camera that records the dynamics or the direct and consensual eye blink.
Measure: Corneal sensation measured using BlinkTBI video apparatus. Time: Done once as baseline for phase 1 of the study and also will be repeated at the end of phase 2 of the study.Description: Schirmer filter strips will be placed in the inferior temporal palpebral conjunctiva and tear production will be assessed after 5 minutes by recording the millimeter wetting of the filter strip for each eye. The tear osmolality will also be determined at this time.
Measure: Tear production using Schirmer filter strips. Time: Done once as baseline for phase 1 of the study and also will be repeated at the end of phase 2 of the study.Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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