Diabetes Peripheral Neuropathy Trial Results
Auum was the product sponsor for a Canadian Diabetes Association funded clinical trial investigating if 12-months of mammalian omega 3 supplementation could stop the progression of Diabetic Peripheral Neuropathy (DPN) in individuals with Type 1 diabetes. Currently there are no known interventions to stop the progression of nerve damage in diabetes.
Results were presented at National and International Conferences in July and September 2016.
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 DPN.
Background: DPN 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 DPN as determined by a Toronto Clinical Neuropathy Score (TCNS)≥1 were recruited to participate in an open-label trial of mammalian Omega 3 PUFA supplementation provided by Auum (10 ml/day 750 mg EPA, 560 mg DPA and 1020 mg DHA) for 1 year (NCT02034266). The primary outcome was the 1-year change in CNFL (Corneal nerve Fibre Length), 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,
(CNFL) was measured in vivo is a biomarker for DPN 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 Auum mammalian omega oil supplementation can stop the progression of DPN measured by CNFL. N-3 supplementation could be a targeted nutritional therapy to address small nerve fiber damage in DPN.