School of Medicine and Public Health, University of Newcastle, New Lambton Heights, Australia.
Division of Medicine, Hunter New England Local Health District, New Lambton Heights, Australia.
Acta Diabetol. 2022 Jul;59(7):965-975. doi: 10.1007/s00592-022-01888-x. Epub 2022 Apr 22.
The burden and health costs of Type 2 Diabetes Mellitus continue to increase globally and prevention strategies in at-risk people need to be explored. Previous work, in both animal models and humans, supports the role of zinc in improving glucose homeostasis. We, therefore, aimed to test the effectiveness of zinc supplementation on glycaemic control in pre-diabetic adults.
We conducted a randomized, double-blind, placebo-controlled trial across 10 General Practitioner (GP) practices in NSW, Australia. The trial is known as Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD)Study. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4%, 39-46 mmol/mol) men and women (N = 98) were all assigned to a free state government telephone health coaching service (New South Wales Get Healthy Information and Coaching Service) and then randomised to either daily 30 mg zinc gluconate or placebo. Blood tests were collected at baseline, 1, 6 and 12 months for the primary outcomes (HbA1c, fasting blood glucose (FBG)); secondary outcomes included Homeostasis Model Assessment 2 (HOMA 2) parameters, lipids, body weight, height, waist circumference, blood pressure and pulse.
The baseline-adjusted mean group difference at 6 months, expressed as treatment-placebo, (95% CI) was -0.02 (-0.14, 0.11, p = 0.78) for HbA1c and 0.17 (-0.07, 0.42; p = 0.17) for FBG, neither of which were statistically significant. There were also no significant differences between groups in any of the secondary outcomes. Zinc was well tolerated, and compliance was high (88%).
We believe our results are consistent with other Western clinical trial studies and do not support the use of supplemental zinc in populations with a Western diet. There may still be a role for supplemental zinc in the developing world where diets may be zinc deficient.
Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018.
2 型糖尿病的负担和健康成本在全球范围内持续增加，需要探索高危人群的预防策略。先前的动物模型和人类研究支持锌在改善葡萄糖稳态方面的作用。因此，我们旨在测试锌补充剂对糖尿病前期成年人血糖控制的有效性。
我们在澳大利亚新南威尔士州的 10 家全科医生 (GP) 诊所进行了一项随机、双盲、安慰剂对照试验。该试验被称为锌在预防糖尿病前期进展 (ZIPPeD) 研究。糖尿病前期（糖化血红蛋白 [HbA1c] 5.7-6.4%，39-46mmol/mol）的男性和女性（N=98）均被分配到免费的州政府电话健康辅导服务（新南威尔士州健康信息和辅导服务），然后随机分配接受每日 30mg 葡萄糖酸锌或安慰剂。主要结局（HbA1c、空腹血糖 [FBG]）的基线、1、6 和 12 个月采集血液检测；次要结局包括稳态模型评估 2（HOMA 2）参数、脂质、体重、身高、腰围、血压和脉搏。
6 个月时，经基线调整的组间平均差异（95%CI）表示为治疗-安慰剂，HbA1c 为-0.02（-0.14，0.11，p=0.78），FBG 为 0.17（-0.07，0.42；p=0.17），均无统计学意义。其他次要结局在组间也无显著差异。锌的耐受性良好，依从性高（88%）。
我们认为我们的结果与其他西方临床试验研究一致，不支持在西方饮食人群中使用补充锌。在饮食可能缺锌的发展中国家，补充锌可能仍有作用。
澳大利亚和新西兰临床试验注册中心，ACTRN12618001120268。于 2018 年 7 月 6 日注册。
