小柯机器人

日本北九州职业与环境卫生大学Tetsuya Kawahara团队研究了活性维生素D治疗对2型糖尿病进展的影响。相关论文发表在2022年5月25日出版的《英国医学杂志》上。

为了评估活性维生素D类似物-艾地骨化醇是否能减少糖耐量受损成年人2型糖尿病的发生，2013年6月至2019年8月，研究组在日本的三家医院进行了一项双盲、多中心、随机、安慰剂对照试验，招募通过75g口服葡萄糖耐量试验和糖化血红蛋白水平确定患有糖耐量受损的30岁及以上人群。

将参与者随机分组，其中630例接受活性维生素D治疗，626例接受匹配的安慰剂，为期三年。主要终点是糖尿病的发病率。预先指定的次要终点是在基线校正混杂因素后，回归到正常血糖和2型糖尿病发病率。此外，还评估了骨密度、骨代谢和糖代谢指标。

1256名参与者中，571名（45.5%）为女性，742名（59.1%）有2型糖尿病家族史。参与者的平均年龄为61.3岁。基线时平均血清25-羟基维生素D水平为20.9 ng/mL；548名（43.6%）参与者低于20 ng/mL。

在2.9年的中位随访期间，艾地骨化醇组有79名（12.5%）发生了2型糖尿病，安慰剂组中有89名（14.2%），危险比为0.87。艾地骨化醇组有145名（23.0%）恢复到正常血糖，安慰剂组有126名（20.1%），危险比为1.15，组间差异均不显著。

通过多变量分数多项式Cox回归分析校正混杂因素后，艾地骨化醇显著降低了糖尿病的发生率，危险比为0.69。此外，在基础胰岛素分泌水平较低的参与者中，艾地骨化醇亦显示出有益作用，危险比为0.41。在随访期间，与安慰剂组相比，艾地骨化醇组腰椎和股骨颈的骨密度以及血清骨钙素浓度显著升高。未观察到严重不良事件的显著差异。

研究结果表明，虽然用艾地骨化醇治疗并未显著降低糖尿病前期患者的糖尿病发病率，但研究结果表明，艾地骨化醇对胰岛素分泌不足的患者有潜在益处。

附：英文原文

Title: Effect of active vitamin D treatment on development of type 2 diabetes: DPVD randomised controlled trial in Japanese population

Author: Tetsuya Kawahara, Gen Suzuki, Shoichi Mizuno, Tetsuya Inazu, Fumiyoshi Kasagi, Chie Kawahara, Yosuke Okada, Yoshiya Tanaka

Issue&Volume: 2022/05/25

Abstract:

Objective To assess whether eldecalcitol, an active vitamin D analogue2, can reduce the development of type 2 diabetes among adults with impaired glucose tolerance.

Design Double blinded, multicentre, randomised, placebo controlled trial.

Setting Three hospitals in Japan, between June 2013 and August 2019.

Participants People aged 30 years and older who had impaired glucose tolerance defined by using a 75 g oral glucose tolerance test and glycated haemoglobin level.

Interventions Participants were randomised to receive active vitamin D (eldecalcitol 0.75 μg per day; n=630) or matching placebo (n=626) for three years.

Main outcomes The primary endpoint was incidence of diabetes. Prespecified secondary endpoints were regression to normoglycaemia and incidence of type 2 diabetes after adjustment for confounding factors at baseline. In addition, bone densities and bone and glucose metabolism markers were assessed.

Results Of the 1256 participants, 571 (45.5%) were women and 742 (59.1%) had a family history of type 2 diabetes. The mean age of participants was 61.3 years. The mean serum 25-hydroxyvitamin D concentration at baseline was 20.9 ng/mL (52.2 nmol/L); 548 (43.6%) participants had concentrations below 20 ng/mL (50 nmol/L). During a median follow-up of 2.9 years, 79 (12.5%) of 630 participants in the eldecalcitol group and 89 (14.2%) of 626 in the placebo group developed type 2 diabetes (hazard ratio 0.87, 95% confidence interval 0.67 to 1.17; P=0.39). Regression to normoglycaemia was achieved in 145 (23.0%) of 630 participants in the eldecalcitol group and 126 (20.1%) of 626 in the placebo group (hazard ratio 1.15, 0.93 to 1.41; P=0.21). After adjustment for confounding factors by multivariable fractional polynomial Cox regression analysis, eldecalcitol significantly lowered the development of diabetes (hazard ratio 0.69, 0.51 to 0.95; P=0.020). In addition, eldecalcitol showed its beneficial effect among the participants with the lower level of basal insulin secretion (hazard ratio 0.41, 0.23 to 0.71; P=0.001). During follow-up, bone mineral densities of the lumbar spine and femoral neck and serum osteocalcin concentrations significantly increased with eldecalcitol compared with placebo (all P<0.001). No significant difference in serious adverse events was observed.

Conclusions Although treatment with eldecalcitol did not significantly reduce the incidence of diabetes among people with pre-diabetes, the results suggested the potential for a beneficial effect of eldecalcitol on people with insufficient insulin secretion.

DOI: 10.1136/bmj-2021-066222

Source: https://www.bmj.com/content/377/bmj-2021-066222

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