← Back to Search

Fish Oil for Diabetic Neuropathy

N/A
Waitlist Available
Led By Mark A Yorek, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 5 year known duration of diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

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.

Who is the study for?
This trial is for type 2 diabetes patients over the age of 50 with mild to moderate peripheral neuropathy, who have had diabetes for at least five years and have an HbA1c level below 9.0%. They should not be heavy smokers, on high-dose insulin or fish oil supplements, nor have a history of bleeding disorders or certain other medical conditions that could affect nerve function.Check my eligibility
What is being tested?
The study is testing whether Blackmores Omega Daily (fish oil) can improve corneal nerve density and sensitivity in diabetic patients with neuropathy. It's based on earlier findings suggesting fish oil might help nerve regeneration. The trial will also explore a new method using cornea sensitivity to detect early-stage peripheral neuropathy.See study design
What are the potential side effects?
While specific side effects are not listed here, typical side effects from omega-3 fatty acid supplements like fish oil may include a fishy aftertaste, upset stomach, loose stools, and nausea. More serious side effects are rare but can include increased bleeding if taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had diabetes for at least 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cornea nerve density
Change in corneal sensitivity to hyperosmotic eye drop
Secondary outcome measures
Change in 10 g monofilament test
Change in Michigan neuropathy screening instrument
Change in corneal sensation threshold using Cochet Bonnet filament
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Type 2 diabetes without neuropathyExperimental Treatment1 Intervention
Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation.
Group II: Type 2 diabetes with neuropathyExperimental Treatment1 Intervention
Subjects with type 2 diabetes will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation.
Group III: Normal subjects, aged match with no symptoms of diabetesExperimental Treatment1 Intervention
Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,560 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,163 Total Patients Enrolled
Mark A Yorek, PhDPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Blackmores Omega Daily (4 1g capsules per day) Clinical Trial Eligibility Overview. Trial Name: NCT04222660 — N/A
Diabetic Neuropathy Research Study Groups: Normal subjects, aged match with no symptoms of diabetes, Type 2 diabetes without neuropathy, Type 2 diabetes with neuropathy
Diabetic Neuropathy Clinical Trial 2023: Blackmores Omega Daily (4 1g capsules per day) Highlights & Side Effects. Trial Name: NCT04222660 — N/A
Blackmores Omega Daily (4 1g capsules per day) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222660 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Illinois
How old are they?
65+
What site did they apply to?
Iowa City VA Health Care System, Iowa City, IA
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~10 spots leftby Mar 2025