Omega-3 Fatty Acid Lipidomics in Diabetes Peripheral Neuropathy

Launched by UNIVERSITY OF IOWA · Dec 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a potential treatment for diabetic peripheral neuropathy (DPN), a common and painful condition affecting people with diabetes. The researchers want to find out if taking fish oil, which is rich in omega-3 fatty acids, combined with a medication called salsalate can help improve symptoms of DPN. Both fish oil and salsalate are believed to have anti-inflammatory effects that might protect nerve health. Participants will take either 2g or 4g of fish oil daily for four months, and then add salsalate for an additional two months. The goal is to see how these treatments affect the levels of omega-3 fatty acids in the blood and other markers related to nerve health.

To be eligible for this study, participants must be 18 years or older, diagnosed with type 2 diabetes and DPN, and have a specific level of blood sugar control. They should not have other causes of neuropathy or certain health conditions that could complicate the study. If you decide to participate, you'll be closely monitored for your health, and the researchers will check how well the treatment is working. This trial is important because there are currently no effective treatments for DPN, and the findings could lead to new options for managing this painful condition.

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Eligibility criteria

• Inclusion Criteria:
• • 1. T2D according to American Diabetes Association (ADA) criteria (38).
• • 2. Age ≥ 18 yr.
• • 3. HbA1c \< 9.5%.
• • 4. Presence of DPN based on Michigan Neuropathy Screening Instrument (combined questionnaire and a clinical examination of the response to vibration perception examination using a 128 Hz tuning fork and ankle reflexes), a validated, sensitive, and specific instrument for the diagnosis of DPN as reported (39,40). Pin prick sensation will be performed (as measures of small-fiber neuropathy) for DPN confirmation (41-43).
• • 5. Be willing and capable of providing a written consent form and willing and able to cooperate with the medical procedures for the study duration.
• • 6. Women of childbearing potential must be willing to use appropriate contraception during the entire trial.
• Exclusion Criteria:
• • 1. History of any other causes of neuropathy (e.g. other neurological disorders, medications-induced, occupational history, active hepatitis C infection, exposure to toxins).
• • 2. History of persistent macroalbuminuria \[random urine microalbumin creatinine ratio (ACR) up to 300 mg/gm\]is acceptable if calculated GFR is \>60 (16).
• • 3. Serum creatinine \>1.4 for women and \>1.5 for men or eGFR \<60 \[calculated using the CKD-EPI equation\].
• • 4. Use of warfarin (Coumadin), clopidogrel (Plavix), dipyridamole (Persantine), heparin or other anticoagulants, probenecid (Benemid, Probalan), sulfinpyrazone (Anturane) or other uricosuric agents; Participants must agree to not use high-dose aspirin during the course of the study. Daily low-dose aspirin treatment (not more than 81 mg per day) may be continued if currently prescribed.
• • 5. Uncontrolled hypertension
• • 6. Triglyceride \> 400 mg/100ml.
• • 7. History of previous organ transplantation (kidney, pancreas, liver, lung or cardiac transplantation).
• • 8. History of drug or alcohol abuse within 5 years, or current weekly alcohol consumption \>10 units/week.
• • 9. Pregnancy or lactation or desire to become pregnant in the next 12 months
• • 10. Requiring long-term glucocorticoid therapy or chronic immunosuppressive therapy: inhaled steroid use for management of asthma is not an absolute exclusion. .
• • 11. Participation in an experimental medication trial within 3 months of starting the study.
• • 12. Current therapy for malignant disease other than basal cell or squamous cell skin cancer.
• • 13. History of gastrointestinal bleeding or active gastric ulcer;
• • 14. Screening laboratory abnormalities including AST (SGOT) and or ALT (SGPT) \> 2.5 x the upper limit of normal (ULN), total bilirubin \> 1.5 x ULN, platelets \< 100,000;
• • 15. History of taking fish oil supplements in the 6 months prior to the screening visit.
• • 16. History of fish or shellfish allergy.
• • 17. Presence of any condition that in the opinion of the investigators would make it unlikely for the participant to complete study.
• • 18. Known hypersensitivity to salsalate or inactive ingredients. Patients who have experienced asthma, hives, or other allergic-type reactions to aspirin or other NSAIDs are excluded from participation.
• • 19. Use of lithium.
• • 20. Absent one or both great toes.