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Fish Oil for Diabetic Neuropathy
Study Summary
This trial is testing whether changes in cornea sensitivity can be used to detect peripheral neuropathy in its early stages, and whether fish oil treatment can improve corneal nerve density and sensitivity in subjects with diabetic neuropathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your HbA1c level is less than 9.0%.You have been diagnosed with type 2 diabetes by Dr. Correia, and have not experienced ketoacidosis. Your C-peptide level is greater than 0.8 ng/ml.I have a condition that affects my nerve or muscle function.I am at risk of bleeding or take medication that increases this risk.I have a history of taking aspirin.I have had a diabetic foot ulcer in the past.I have a condition that affects blood or tissue oxygen levels.I use insulin for my diabetes, but no more than 200 units daily.I am over 50 and not pregnant, trying to get pregnant, or breastfeeding.I have had diabetes for at least 5 years.I have little to no nerve pain in my hands and feet.I have little to no nerve pain in my hands and feet.I have had diabetes for at least 5 years.
- Group 1: Normal subjects, aged match with no symptoms of diabetes
- Group 2: Type 2 diabetes without neuropathy
- Group 3: Type 2 diabetes with neuropathy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the cap on participation for this clinical experiment?
"Indeed, the data on clinicaltrials.gov affirms this medical trial's recruitment status and reveals that it was initially posted in June 2021 with a recent update on September 2nd 2022. The study is aiming to reach 75 participants across one site."
What end result are researchers aiming to achieve with this trial?
"The primary outcome measure of this clinical trial is a change in corneal sensitivity to hyperosmotic eye drops, whereas the secondary outcomes are changes in hot or cold sensation, omega-3 polyunsaturated fatty acids and their metabolites in serum, as well as Michigan neuropathy screening instrument. To evaluate responses to heat and cold stimuli, participants will wear a Velcro strap containing a metal circular pad on their right foot - pushing the button of an accompanying hand held device when they feel either temperature. The duration of this study spans 12 months with measurements taken at the beginning and end points."
What qualifications do potential participants need to possess in order to be accepted into this research program?
"Participants aged between 50 and 75 are eligible to take part in this trial if they have been diagnosed with one of the peripheral nervous system diseases. A total of 75 individuals will be admitted into the study."
Are there any available openings for this experiment?
"Affirmative. According to clinicaltrials.gov, the study is actively recruiting eligible participants. It was first posted on June 21st 2021 and last edited on September 2nd 2022; it requires 75 volunteers from a single site for its completion."
Does the age criterion for this research encompass persons below 40 years?
"To be eligible for this trial, individuals must fall between the ages of 50-75. There are also 5 trials available to younger than 18 and 156 studies open to those over 65 years old."
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