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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up done once as a determination of the presence of peripheral neuropathy
Awards & highlights

Summary

This trial is testing whether fish oil supplements can help people with type 2 diabetes who have nerve damage. The study aims to see if fish oil can repair damaged nerves and improve their function. If successful, this could provide a new treatment option for diabetic nerve damage.

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.
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.
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.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cornea Sensitivity
Secondary study objectives
Change in Corneal Sensation Threshold Using Cochet Bonnet Filament
Determination of Tibial Nerve Conduction Velocity
Michigan Neuropathy Screening Instrument
+5 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Fish oil, which is rich in omega-3 fatty acids, is being studied for its potential to improve nerve regeneration and increase corneal nerve density and sensitivity in diabetic neuropathy patients. This is significant because diabetic neuropathy involves nerve damage and loss of function, leading to complications such as pain, numbness, and even loss of mobility. By promoting nerve regeneration and enhancing nerve density, fish oil could help alleviate these symptoms and improve the overall quality of life for patients. Other treatments for diabetic neuropathy generally aim to manage symptoms and control blood glucose levels, but fish oil's potential to directly improve nerve health represents a promising therapeutic approach.
Diagnostic utility of corneal confocal microscopy in type 2 diabetic peripheral neuropathy.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,026 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,847 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
~11 spots leftby Sep 2025