44 Participants Needed

Fish Oil for Diabetic Neuropathy

MA
RH
Overseen ByRandy H Kardon, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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.

What evidence supports the effectiveness of the treatment Blackmores Omega Daily for diabetic neuropathy?

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 animals and humans have shown that omega-3 supplements can improve nerve conduction and reduce pain in diabetic neuropathy, indicating potential benefits for similar treatments like Blackmores Omega Daily.12345

Is fish oil safe for humans?

Fish oil, which contains omega-3 fatty acids, is generally considered safe for humans and has been studied for various health benefits, including potential improvements in diabetic neuropathy.12467

How does fish oil treatment differ from other treatments for diabetic neuropathy?

Fish oil, particularly rich in omega-3 fatty acids, is unique because it may improve nerve function and sensitivity in diabetic neuropathy by reducing inflammation and providing neuroprotective benefits, unlike many standard treatments that primarily focus on managing blood sugar levels.12367

Research Team

MA

Mark A Yorek, PhD

Principal Investigator

Iowa City VA Health Care System, Iowa City, IA

Eligibility Criteria

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
I have a condition that affects my nerve or muscle function.
BP < 140 systolic and 80 diastolic
See 11 more

Timeline

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

Treatment Details

Interventions

  • Blackmores Omega Daily
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

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+

Findings from Research

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

References

The Potential Role of Fatty Acids in Treating Diabetic Neuropathy. [2019]
Effect of omega-3 supplementation on neuropathy in type 1 diabetes: A 12-month pilot trial. [2022]
Enriching the diet with menhaden oil improves peripheral neuropathy in streptozotocin-induced type 1 diabetic rats. [2022]
The effect of gamma-linolenic acid on human diabetic peripheral neuropathy: a double-blind placebo-controlled trial. [2022]
Fish oil supplementation prevents diabetes-induced nerve conduction velocity and neuroanatomical changes in rats. [2022]
Effect of enriching the diet with menhaden oil or daily treatment with resolvin D1 on neuropathy in a mouse model of type 2 diabetes. [2022]
Partial replacement with menhaden oil improves peripheral neuropathy in high-fat-fed low-dose streptozotocin type 2 diabetic rat. [2022]