Aim

In this randomized placebo-controlled clinical trial, effect of oral inorganic nitrate (NO₃⁻) on metabolic parameters was assessed in patients with type 2 diabetes mellitus (T2DM).

Methods

Seventy-four eligible patients with T2DM were randomly assigned to NO₃⁻-rich beetroot powder (5 g/d contains ~250 mg NO₃⁻) and placebo groups to complete intervention over a 24-week period. Blood HbA1c, fasting serum glucose, insulin, C-peptide, as well as lipid profile were assessed at baseline and again at weeks 4, 12, and 24; indices of insulin resistance were also calculated. To assess safety of long-term oral NO₃⁻, liver and renal function tests were measured. An intention-to-treat approach was used for data analysis. To compare effect of intervention over time between the groups (time×group), repeated measures generalized estimating equation (GEE) linear regression models were used.

Results

Mean age of the participants was 54.0 ± 8.5 (47.9% were male) and mean duration of diabetes was 8.5 ± 6.1 years. A total of 64 patients (n = 35 in beetroot group and n = 29 in placebo group) completed at least two visits and were included in the analyses. No significant difference was observed between the groups for glycemic and lipid parameters over time. Liver and renal function tests, as safety outcome measures, showed no undesirable changes during the study follow-up.

Conclusion

Supplementation with inorganic NO₃⁻ had no effect on metabolic parameters in patients with T2DM.

中文翻译：

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无机硝酸盐对2型糖尿病患者代谢参数的影响：一项为期24周的随机双盲安慰剂对照临床试验

目标

在该随机安慰剂对照临床试验中，口服无机硝酸盐（NO的效果₃ ^- ）对代谢参数在治疗2型糖尿病（T2DM）进行了评估。

方法

七十四合格T2DM患者被随机分配到NO ₃ ^-富甜菜粉末（5克/ d包含〜250毫克NO ₃ ^- ）在24周的时间组和安慰剂组，以完整的干预。在基线时以及在第4、12和24周再次评估血液HbA1c，空腹血糖，胰岛素，C-肽以及脂质分布。还计算了胰岛素抵抗指数。为了评估长期口服NO的安全性₃ ^- ，肝，肾功能检查，测定。意向治疗方法用于数据分析。为了比较各组（时间×组）随时间的干预效果，使用了重复测量广义估计方程（GEE）线性回归模型。

结果

参与者的平均年龄为54.0±8.5（男性为47.9％），糖尿病的平均病程为8.5±6.1岁。总共64位患者（甜菜根组n = 35，安慰剂组n = 29）完成了至少两次访视，并纳入了分析。随着时间的推移，两组之间的血糖和脂质参数均未观察到显着差异。肝肾功能检查作为安全性指标，在研究随访期间未显示不良变化。

结论

补充无机NO ₃ ^-曾在2型糖尿病患者的代谢参数没有影响。