Fish Oil for Diabetic Neuropathy

Overseen By Randy H Kardon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Aspirin, Fish oil, others

Disqualifiers: Neurologic, Muscular, Genetic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fish oil, specifically Blackmores Omega Daily, can aid individuals with diabetic neuropathy, a condition causing nerve damage and affecting about half of those with diabetes. Researchers will first examine changes in eye sensitivity to detect early signs of nerve damage. Then, they will assess whether fish oil can improve nerve health in those already experiencing neuropathy. Individuals with type 2 diabetes and mild nerve issues may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new insights and treatments for diabetic neuropathy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that increase the risk of bleeding or have a history of taking aspirin, you may be excluded from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that fish oil, which contains omega-3 fatty acids, is generally safe for people. Some studies suggest that fish oil might help with diabetic neuropathy, the nerve damage caused by diabetes. In animal studies, fish oil helped nerves heal and regenerate.

Most people tolerate fish oil well. However, some studies found that omega-3 supplements did not significantly reduce nerve pain compared to a placebo. Always consult a doctor before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic neuropathy, which often include medications like gabapentin or duloxetine to manage pain, Blackmores Omega Daily is unique because it focuses on the potential benefits of omega-3 fatty acids. Omega-3s are known for their anti-inflammatory properties, which might help reduce nerve pain and improve nerve function in those with diabetic neuropathy. Researchers are excited about this treatment because it offers a more natural approach that could complement existing therapies, potentially leading to fewer side effects and additional health benefits, such as improved heart health.

What evidence suggests that fish oil might be an effective treatment for diabetic neuropathy?

This trial will examine the effects of fish oil on diabetic neuropathy. Research suggests that omega-3 fatty acids, found in fish oil, can improve nerve function and reduce symptoms in diabetic neuropathy. Animal studies show that fish oil aids nerve healing and function in diabetic rodents, indicating potential benefits for humans. However, recent research suggests that omega-3 supplements may offer little to no benefit for diabetic nerve issues. While early results appear promising, further research is necessary to confirm the effectiveness of fish oil for people with diabetic neuropathy. ^{1 2 3 5 6}

Who Is on the Research Team?

Mark A Yorek, PhD

Principal Investigator

Iowa City VA Health Care System, Iowa City, IA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had diabetes for at least 5 years.

Exclusion Criteria

Cigarette smoking in the past year

BMI 45

BP < 140 systolic and 80 diastolic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase 1: Sensitivity Testing

Determine if reflex squinting and blinking response to hyperosmotic solution is impaired in patients with type 2 diabetes

4 weeks

1 visit (in-person)

Phase 2: Fish Oil Treatment

Participants with diabetic neuropathy receive fish oil treatment to assess improvement in corneal nerve density and sensitivity

12 months

3 visits (in-person) at 4, 8, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blackmores Omega Daily

Trial Overview 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.

How Is the Trial Designed?

Group I: Type 2 diabetes without neuropathy Experimental Treatment 1 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 neuropathy Experimental Treatment 1 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 diabetes Experimental Treatment 1 Intervention

Healthy, aged matched control subjects will be enrolled and determination if they have neuropathy will be determined from their clinical record and evaluation.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Pre-clinical studies indicate that omega-3 fatty acids, particularly eicosapentaenoic and docosahexaenoic acids, can improve and potentially reverse nerve and blood vessel damage in diabetic rodents, suggesting a promising treatment for diabetic peripheral neuropathy.

Metabolites of omega-3 fatty acids, known as resolvins, have been shown to promote nerve growth in cell cultures and provide similar benefits for peripheral neuropathy in diabetic mice, highlighting their potential therapeutic role, although further clinical trials are necessary to confirm these effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Role of Fatty Acids in Treating Diabetic Neuropathy. Yorek, MA.[2019]

In a study of 22 patients with distal diabetic polyneuropathy, those who received 360 mg of gamma-linolenic acid for 6 months showed significant improvements in neuropathy symptoms and nerve function compared to a placebo group.

Gamma-linolenic acid supplementation led to better scores in nerve conduction velocities and sensory nerve action potentials, suggesting it could be an effective treatment for managing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of gamma-linolenic acid on human diabetic peripheral neuropathy: a double-blind placebo-controlled trial. Jamal, GA., Carmichael, H.[2022]

Citations

1. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-5-2021-870d2

Fish Oil for Diabetic Neuropathy · Info for Participants Research suggests that omega-3 fatty acids, like those found in fish oil, can help improve nerve function and reduce symptoms in diabetic neuropathy. Studies on ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28530530/

Is Fish Oil a Potential Treatment for Diabetic Peripheral ... Existing data suggests that dietary enrichment with omega-3 fatty acids contained in fish oil may be beneficial treatment for diabetic neuropathy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04222660

NCT04222660 | Corneal Nerves Function and Structure The investigators will examine the effect of fish oil treatment of diabetic subjects with neuropathy on corneal nerve density and sensitivity.

4. research.va.gov research.va.gov/currents/fall2014/fall2014-31.cfm

In Iowa VA lab study, fish oil eases diabetic neuropathy "These results suggest that enriching the diet with omega-3 fatty acids may be a good treatment strategy for diabetic neuropathy." Importantly, ...

5. emjreviews.com emjreviews.com/diabetes/news/omega-3-supplements-show-limited-benefit-for-diabetic-neuropathy/

Limited Support for Omega-3 in Diabetic Neuropathy New data suggests omega-3 supplements provide little to no benefit for diabetic polyneuropathy.

6. cochrane.org cochrane.org/evidence/CD014623_what-are-benefits-and-risks-omega-3-supplements-treating-nerve-damage-adults-diabetes

What are the benefits and risks of omega-3 supplements ... Compared with placebo treatment, omega-3 fatty acid supplements taken for six months may make little or no difference to peripheral neuropathy ...