Effect of omega-3 supplementation on neuropathy in type 1 diabetes A 12-month pilot trial

Effect of omega-3 supplementation on neuropathy in type 1 diabetes A 12-month pilot trial
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DOI:
10.1212/wnl.0000000000004033
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发表时间:
2017-06-13
期刊:
影响因子:
9.9
通讯作者:
Bril, Vera
Bril, Vera
中科院分区:
医学1区
文献类型:
--
作者:
Lewis, Evan J. H.;Perkins, Bruce A.;Bril, Vera

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目的:验证海豹油omega-3多不饱和脂肪酸(omega-3 PUFA)补充12个月将阻止1型糖尿病(T1DM)患者糖尿病感觉运动多神经病变(DSP)的已知进展的假设。方法:招募有T1DM和DSP证据(多伦多临床神经病变评分>= 1)的个体参加一项单臂、开放标签的海豹油omega-3 PUFA补充试验(10 mL.d(-1);750毫克二十碳五烯酸,560毫克二十二碳五烯酸,1020毫克二十二碳六烯酸)1年。主要终点是角膜共聚焦显微镜测量角膜神经纤维长度(CNFL)的1年变化,感觉和神经传导测量作为次要终点。结果:纳入40名参与者(53%为女性),年龄48 +/- 14岁,体重指数28.1 +/- 5.8,糖尿病病程27 +/- 18年。在基线时,23名参与者有临床DSP, 17名没有。基线CNFL为8.3 +/- 2.9 mm/mm(2),补充12个月后增加29%至10.1 +/- 3.7 mm/mm(2) (p = 0.002)。神经传导和感觉功能没有变化。结论:12个月的omega-3补充与t1dm患者CNFL增加有关。govidentifier: NCT02034266。证据分类:本研究提供IV类证据,对于T1DM和DSP患者,补充12个月海豹油omega-3可增加CNFL。
Objective: To test the hypothesis that 12 months of seal oil omega-3 polyunsaturated fatty acids (omega-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 omega-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/mm(2) and increased 29% to 10.1 +/- 3.7 mm/mm(2) (p = 0.002) after 12 months of supplementation. There was no change in nerve conduction or sensory function.Conclusions: Twelve months of omega-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.