Diabetes Neuropathy Trial In Analysis
Auum was the product sponsor for a Canadian Diabetes Association funded clinical trial investigating if 12-months of seal oil supplementation could stop the progression of diabetic neuropathy in individuals with Type 1 diabetes. Currently there are no known interventions to stop the progression of nerve damage in diabetes.
Data collection for this trial is complete and the research team is very excited to be working on the analysis of this potentially groundbreaking study. Results were presented at National and International Conferences in July and September 2017.
Omega-3 polyunsaturated fatty acids (N-3 PUFA) are essential for the development and maintenance of nerves, but have not yet been investigated for their ability to stop the progression of DSP.
Background: Diabetic peripheral neuropathy (DSP) is the leading complication in diabetes mellitus (DM) for which there are currently no intervention therapies.
Methods: Individuals with type 1 (T1DM) and evidence of DSP as determined by a Toronto Clinical Neuropathy Score (TCNS)≥1 were recruited to participate in an open-label trial of seal oil N-3 PUFA supplementation provided by Auum (10 mL.d-1; 750 mg EPA, 560 mg DPA and 1020 mg DHA) for 1 year (NCT02034266). The primary outcome was the 1-year change in CNFL, and secondary outcomes included gold-standard clinic tests.
Results: Forty participants (53% female), aged 48±14, BMI 28.1±5.8 with diabetes duration of 27±18 years were enrolled in the trial. At baseline, 27 participants had clinical DSP and 7 were at risk for future DSP. After 12 months,
Corneal nerve fibre length (CNFL) was measured in vivo is a biomarker for DSP onset and progression. An annual CNFL change of -1.6% (shortening)in type 1 diabetes mellitus, while healthy controls change +5% (growth). This double blinded study result showed an Baseline CNFL was 8.3±2.9 mm/mm2 and increased 29% to 10.1±3.7 mm/mm2(p=0.006).
Conclusion: These finding show that 12 months of seal oil supplementation can stop the progression of DSP measured by CNFL. N-3 supplementation could be a targeted nutritional therapy to address small nerve fibre damage in DSP.