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Omega-3 Fatty Acid

Fish Oil + Salsalate for Diabetic Neuropathy

Phase 1 & 2

Recruiting

Led By Rodica Pop-Busui, MD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T2D according to American Diabetes Association (ADA) criteria

Age ≥ 18 yr

Must not have

Use of lithium

History of any other causes of neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 16 weeks and 24 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the combination of fish oil and salsalate to see if it is an effective treatment for diabetic peripheral neuropathy (DPN). DPN is a common complication of diabetes that can lead to severe pain, sensory deficits, foot ulcers, and amputations. There is no currently no effective treatment for DPN.

Who is the study for?

Adults over 18 with type 2 diabetes and diabetic peripheral neuropathy can join this trial. They should have an HbA1c level below 9.5% and be willing to use contraception if necessary. People with other types of neuropathy, severe kidney issues, recent transplants, or certain medical conditions that could interfere with the study cannot participate.

What is being tested?

The trial is testing whether taking fish oil capsules (rich in omega-3 fatty acids) alone or combined with salsalate tablets can help people with diabetic nerve pain by changing their blood lipid profile and increasing anti-inflammatory metabolites.

What are the potential side effects?

Possible side effects include minor risks associated with fish oil such as a fishy aftertaste, nausea, and loose stools. Salsalate may cause stomach upset, ringing in the ears, or allergic reactions for those sensitive to it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 2 Diabetes.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking lithium.

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I have a history of conditions that cause nerve damage.

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I am currently taking medications like warfarin or aspirin.

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I have had an organ transplant in the past.

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I am missing one or both of my great toes.

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I am not receiving treatment for any cancer except for skin cancer.

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My kidney function is reduced, with specific creatinine levels or eGFR below 60.

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My high blood pressure is not under control.

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I am on long-term steroids or drugs that suppress my immune system.

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I have had stomach bleeding or currently have a stomach ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 16 weeks and 24 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 16 weeks and 24 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 16 weeks and 24 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline of omega-3 index at 16 and 24 weeks

Secondary study objectives

Change from baseline in diabetic peripheral neuropathy symptoms score after 24 weeks using the Michigan Neuropathy Screening Instrument.

Change from baseline in fasting blood glucose after 16 and 24 weeks.

Change from baseline in fasting blood lipids (triglycerides and low- and high-density cholesterol) after 16 and 24 weeks.

+12 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Fish oil capsulesExperimental Treatment1 Intervention

Subjects will be randomized for the treatment of fish oil capsules. Subjects will take daily supplements of two or four fish oil capsules per day, 2 and 4 g respectively. Treatment will continue for 16 weeks. Fish oil capsules are enriched in omega-3 polyunsaturated fatty acids.

Group II: Fish oil and SalsalateExperimental Treatment2 Interventions

Salsalate is a non-steroid anti-inflammatory drug. Subjects taking 2 or 4g of fish oil capsules will be randomized to take in addition 1.5 or 3.0 g of salsalate per day. The combined treatment of fish oil and salsalate will continue for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fish Oil Concentrate, 1000 Mg Oral Capsule

2021

N/A

~180

0 / 12Eligibility criteria met