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Abstract
Objective: To test the hypothesis that 12 months of seal oil omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation will stop the known progression of diabetic sensorimotor polyneuropathy (DSP) in type 1 diabetes mellitus (T1DM).
Methods: Individuals with T1DM and evidence of DSP as determined by a Toronto Clinical Neuropathy Score ≥1 were recruited to participate in a single-arm, open-label trial of seal oil ω-3 PUFA supplementation (10 mL·d−1; 750 mg eicosapentaenoic acid, 560 mg docosapentaenoic acid, and 1,020 mg docosahexaenoic acid) for 1 year. The primary outcome was the 1-year change in corneal nerve fiber length (CNFL) measured by in vivo corneal confocal microscopy, with sensory and nerve conduction measures as secondary outcomes.
Results: Forty participants (53% female), aged 48 ± 14 years, body mass index 28.1 ± 5.8 with diabetes duration of 27 ± 18 years, were enrolled. At baseline, 23 participants had clinical DSP and 17 did not. Baseline CNFL was 8.3 ± 2.9 mm/mm2 and increased 29% to 10.1 ± 3.7 mm/mm2 (p = 0.002) after 12 months of supplementation. There was no change in nerve conduction or sensory function.
Conclusions: Twelve months of ω-3 supplementation was associated with increase in CNFL in T1DM.
ClinicalTrials.govidentifier: NCT02034266.
Classification of evidence: This study provides Class IV evidence that for patients with T1DM and evidence of DSP, 12 months of seal oil omega-3 supplementation increases CNFL.
GLOSSARY
- BMI=
- body mass index;
- CNBD=
- corneal nerve branch density;
- CNFA=
- corneal nerve fiber area;
- CNFD=
- corneal nerve fiber density;
- CNFL=
- corneal nerve fiber length;
- DHA=
- docosahexaenoic acid;
- DM=
- diabetes mellitus;
- DSP=
- diabetic sensorimotor polyneuropathy;
- HRV=
- heart rate variability;
- IVCCM=
- in vivo corneal confocal microscopy;
- LDIFLARE=
- laser Doppler imaging flare technique;
- mTCNS=
- modified Toronto Clinical Neuropathy Score;
- NPD1=
- neuroprotectin D1;
- T1DM=
- type 1 diabetes mellitus;
- TCNS=
- Toronto Clinical Neuropathy Score;
- ω-3 PUFA=
- omega-3 polyunsaturated fatty acid
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Supplemental data at Neurology.org
- Received October 14, 2016.
- Accepted in final form March 21, 2017.
- © 2017 American Academy of Neurology
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