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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
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 belowSelect...
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:Select...
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline of omega-3 index at 16 and 24 weeks
Secondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
460 Previous Clinical Trials
891,734 Total Patients Enrolled
University of MichiganOTHER
1,833 Previous Clinical Trials
6,423,028 Total Patients Enrolled
Rodica Pop-Busui, MDPrincipal InvestigatorProfessor of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to salsalate or any of the inactive ingredients in the medication.You have a history of drug or alcohol abuse within the past 5 years, or you currently drink more than 10 alcoholic drinks per week.You have taken fish oil supplements in the 6 months before the screening visit.I am currently taking lithium.Your HbA1c level is less than 9.5%.I have a history of conditions that cause nerve damage.I am currently taking medications like warfarin or aspirin.I have had an organ transplant in the past.You have had an allergic reaction to fish or shellfish in the past.I am missing one or both of my great toes.I am not receiving treatment for any cancer except for skin cancer.You have diabetic peripheral neuropathy as determined by the Michigan Neuropathy Screening Instrument.I have been diagnosed with Type 2 Diabetes.My kidney function is reduced, with specific creatinine levels or eGFR below 60.I am 18 years old or older.You have a history of long-lasting high levels of protein in your urine.My high blood pressure is not under control.I am on long-term steroids or drugs that suppress my immune system.Your triglyceride levels are higher than 400 mg/100ml.I am willing to use birth control throughout the trial.I have had stomach bleeding or currently have a stomach ulcer.Abnormal test results during the screening process.
Research Study Groups:
This trial has the following groups:- Group 1: Fish oil and Salsalate
- Group 2: Fish oil capsules
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05169060 — Phase 1 & 2
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