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锌补充剂治疗糖尿病前期:一项随机、双盲、安慰剂对照的临床试验。

Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial.

机构信息

Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.

Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.

出版信息

J Diabetes. 2018 May;10(5):386-397. doi: 10.1111/1753-0407.12621. Epub 2018 Jan 3.

Abstract

BACKGROUND

This study evaluated the effects of zinc supplementation on glycemic control, other cardiometabolic and anthropometric parameters, and disease progression in prediabetes.

METHODS

A randomized double-blind placebo-controlled Phase 2 clinical trial was conducted over a 12-month period in 200 subjects (43% male; mean [± SD] age 51.8 ± 7.3 years), randomly assigned (1:  1) to the treatment or control group. The treatment group received zinc (20 mg daily). Subjects were evaluated at baseline and at 1, 3, 6, and 12 months. The primary outcome was the change in glycemic control from baseline. Multiple regression analyses were performed, with change in outcome variables after intervention from baseline used as continuous dependent variables.

RESULTS

In both groups, mean serum zinc concentrations prior to the trial were below normal (15.29-21.41 μmol/L). During the 12-month follow-up, a significantly higher percentage of participants developed type 2 diabetes in the control compared with zinc-treated group (25.0% vs 11.0% respectively; P = 0.016). Fasting plasma glucose (FPG), 2-h glucose levels in the oral glucose tolerance test (OGTT), homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) were significantly lower in the treated group, with significant improvement in β-cell function. In all four regression models, the best predictor of the dependent variables (i.e. change in FPG, 2-h glucose in the OGTT, HOMA-IR, and homeostatic model assessment of β-cell function) was zinc treatment.

CONCLUSIONS

Zinc supplementation reduced blood glucose and insulin resistance while improving β-cell function. Furthermore, supplementation reduced disease progression to diabetes and had beneficial effects on TC and LDL-C.

摘要

背景

本研究评估了补锌对糖尿病前期患者血糖控制、其他心血管代谢和人体测量参数以及疾病进展的影响。

方法

在 200 名受试者(43%为男性;平均[±SD]年龄 51.8±7.3 岁)中进行了一项为期 12 个月的随机、双盲、安慰剂对照的 2 期临床试验,这些受试者被随机分为治疗组和对照组(1:1)。治疗组每天接受锌(20mg)治疗。受试者在基线和 1、3、6 和 12 个月时进行评估。主要结局是从基线开始的血糖控制变化。采用多元回归分析,以干预后结局变量的变化作为连续因变量。

结果

两组受试者试验前的血清锌浓度均低于正常值(15.29-21.41 μmol/L)。在 12 个月的随访期间,对照组中比锌治疗组有更多的参与者发展为 2 型糖尿病(分别为 25.0%和 11.0%;P=0.016)。空腹血糖(FPG)、口服葡萄糖耐量试验(OGTT)中 2 小时血糖水平、稳态模型评估胰岛素抵抗(HOMA-IR)、总胆固醇(TC)和低密度脂蛋白胆固醇(LDL-C)在治疗组中显著降低,β细胞功能也有显著改善。在所有四个回归模型中,预测因变量(即 FPG 的变化、OGTT 中 2 小时血糖、HOMA-IR 和稳态模型评估的β细胞功能)的最佳因素是锌治疗。

结论

补锌可降低血糖和胰岛素抵抗,同时改善β细胞功能。此外,补充锌还可降低糖尿病的进展,并对 TC 和 LDL-C 产生有益影响。

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