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ω-3 脂肪酸补充剂可改善 1 型糖尿病患儿早期糖尿病肾病和亚临床动脉粥样硬化:一项随机对照试验。

Omega-3 fatty acids supplementation improves early-stage diabetic nephropathy and subclinical atherosclerosis in pediatric patients with type 1 diabetes: A randomized controlled trial.

机构信息

Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

出版信息

Clin Nutr. 2023 Dec;42(12):2372-2380. doi: 10.1016/j.clnu.2023.10.007. Epub 2023 Oct 13.

DOI:10.1016/j.clnu.2023.10.007
PMID:37862823
Abstract

BACKGROUND

Numerous studies have evaluated the beneficial effects of omega-3 fatty acids on inflammatory, autoimmune and renal diseases. However, data about the effects of omega-3 fatty acids on diabetic kidney disease in type 1 diabetes mellitus (T1DM) are lacking.

OBJECTIVES

This randomized-controlled trial assessed the effect of oral omega-3 supplementation on glycemic control, lipid profile, albuminuria level, kidney injury molecule-1 (KIM-1) and carotid intima media thickness (CIMT) in pediatric patients with T1DM and diabetic nephropathy.

METHODS

Seventy T1DM patients and diabetic nephropathy were enrolled with a mean age 15.2 ± 1.96 years and median disease duration 7 years. Patients were randomly assigned into two groups; intervention group which received oral omega-3 fatty acids capsules (1 g daily). The other group received a matching placebo and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, fasting lipids, urinary albumin creatinine ratio (UACR), KIM-1 and CIMT.

RESULTS

After 6 months, omega-3 fatty acids adjuvant therapy for the intervention group resulted in a significant decrease in FBG, HbA1c, triglycerides, total cholesterol, LDL-cholesterol, UACR, KIM-1 and CIMT, whereas, HDL-cholesterol was significantly higher post-therapy compared with baseline levels and compared with the control group (p < 0.05). Baseline KIM-1 levels were positively correlated to HbA1c, UACR and CIMT. Supplementation with omega-3 fatty acids was safe and well-tolerated.

CONCLUSIONS

Omega-3 fatty acids as an adjuvant therapy in pediatric T1DM patients with diabetic nephropathy improved glycemic control, dyslipidemia and delayed disease progression and subclinical atherosclerosis among those patients. This trial was registered under ClinicalTrials.gov Identifier no. NCT05980026.

摘要

背景

许多研究已经评估了 ω-3 脂肪酸对炎症、自身免疫和肾脏疾病的有益影响。然而,关于 ω-3 脂肪酸对 1 型糖尿病(T1DM)患者糖尿病肾病的影响的数据尚缺乏。

目的

本随机对照试验评估了口服 ω-3 补充剂对 T1DM 合并糖尿病肾病患儿的血糖控制、血脂谱、白蛋白尿水平、肾损伤分子-1(KIM-1)和颈动脉内膜中层厚度(CIMT)的影响。

方法

共纳入 70 例 T1DM 合并糖尿病肾病患者,平均年龄为 15.2±1.96 岁,中位病程为 7 年。患者被随机分为两组:干预组接受口服 ω-3 脂肪酸胶囊(每天 1g)治疗。另一组接受匹配的安慰剂作为对照组。两组均随访 6 个月,评估空腹血糖(FBG)、HbA1c、空腹血脂、尿白蛋白肌酐比(UACR)、KIM-1 和 CIMT。

结果

6 个月后,ω-3 脂肪酸辅助治疗组的 FBG、HbA1c、三酰甘油、总胆固醇、LDL-胆固醇、UACR、KIM-1 和 CIMT 显著降低,而 HDL-胆固醇治疗后显著高于基线水平,且高于对照组(p<0.05)。基线 KIM-1 水平与 HbA1c、UACR 和 CIMT 呈正相关。ω-3 脂肪酸补充剂是安全且耐受良好的。

结论

ω-3 脂肪酸作为辅助治疗,可改善儿科 T1DM 合并糖尿病肾病患者的血糖控制、血脂异常,延缓疾病进展和亚临床动脉粥样硬化。该试验在 ClinicalTrials.gov 注册号为 NCT05980026 下注册。

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