What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for diabetic neuropathy include medications like anticonvulsants, antidepressants, and pain relievers. For treatments similar to fish oil, such as omega-3 fatty acids, side effects are generally mild but can include gastrointestinal issues like diarrhea, nausea, and fishy aftertaste. High doses may increase bleeding risk, especially in patients taking anticoagulants. Overall, omega-3 fatty acids are well-tolerated but should be used under medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic neuropathy, primarily focusing on pain management rather than nerve regeneration. These include medications such as pregabalin (Lyrica), duloxetine (Cymbalta), and tapentadol (Nucynta). While these drugs help manage symptoms, they do not address nerve regeneration. Fish oil, which is being studied for its potential to improve nerve regeneration and increase corneal nerve density and sensitivity, represents a novel approach. Currently, there are no FDA-approved treatments specifically targeting nerve regeneration in diabetic neuropathy.

What other types of research exist?

Promising alternatives to fish oil for diabetic neuropathy patients include: 1) Evening Primrose Oil, which has shown efficacy in improving nerve conduction velocity in diabetic rats. 2) Omega-6 essential fatty acids, such as linoleic acid and gamma-linolenic acid, which have modestly improved ocular symptoms and signs in small trials. 3) Investigational therapies like Lacritin and Thymosin beta-4, which are being tested for their regenerative and anti-inflammatory properties.

← 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

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

No Placebo-Only Group

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 weeks3 visits

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.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

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.