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评估胰岛素类型(超短效与短效胰岛素)和运动时机对 1 型糖尿病个体餐后运动诱发低血糖风险的影响:一项随机对照试验。

Assessing the influence of insulin type (ultra-rapid vs rapid insulin) and exercise timing on postprandial exercise-induced hypoglycaemia risk in individuals with type 1 diabetes: a randomised controlled trial.

机构信息

Institut de recherches cliniques de Montréal, Montréal, QC, Canada.

Département de Nutrition, Faculté de Médecine, Université de Montréal, Montréal, QC, Canada.

出版信息

Diabetologia. 2024 Nov;67(11):2408-2419. doi: 10.1007/s00125-024-06234-0. Epub 2024 Jul 29.

Abstract

AIMS/HYPOTHESIS: The relationship between pre-meal insulin type, exercise timing and the risk of postprandial exercise-induced hypoglycaemia in people living with type 1 diabetes is unknown. We aimed to evaluate the effects of exercise timing (60 vs 120 min post meal) and different insulin types (aspart vs ultra-rapid aspart) on hypoglycaemic risk.

METHODS

This was a four-way crossover randomised trial including 40 individuals with type 1 diabetes using multiple daily injections (mean HbA 56 mmol/mol [7.4%]). Participants, who were recruited from the Montreal Clinical Research Institute, undertook 60 min cycling sessions (60% of ) after breakfast (60 min [EX60min] or 120 min [EX120min] post meal) with 50% of their usual insulin dose (aspart or ultra-rapid aspart). Eligibility criteria included age ≥18 years old, clinical diagnosis of type 1 diabetes for at least 1 year and HbA ≤80 mmol/mol (9.5%). Participants were allocated using sequentially numbered, opaque sealed envelopes. Participants were masked to their group assignment, and each participant was allocated a unique identification number to ensure anonymisation. The primary outcome was change in blood glucose levels between exercise onset and nadir.

RESULTS

Prior to exercise onset, time spent in hyperglycaemia was lower for EX60min vs EX120min (time >10.0 mmol/l: 56.6% [1.2-100%] vs 78.0% [52.7-97.9%]; p<0.001). The glucose reduction between exercise onset and nadir was less pronounced with EX60min vs EX120min (-3.8±2.7 vs -4.7±2.5 mmol/l; p<0.001). A similar number of hypoglycaemic events occurred during both exercise timings. Blood glucose between exercise onset and nadir decreased less with ultra-rapid aspart compared with aspart (-4.1±2.3 vs -4.4±2.8 mmol/l; p=0.037). While a similar number of hypoglycaemic events during exercise were observed, less post-exercise hypoglycaemia occurred with ultra-rapid aspart (n=0, 0%, vs n=15, 38%; p=0.003). No interactions between insulin types and exercise timings were found.

CONCLUSIONS/INTERPRETATION: EX60min blunted the pre-exercise glucose increase following breakfast and was associated with a smaller glucose reduction during exercise. Ultra-rapid aspart led to a smaller blood glucose reduction during exercise and might be associated with diminished post-exercise hypoglycaemia.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03659799 FUNDING: This study was funded by Novo Nordisk Canada.

摘要

目的/假设:对于 1 型糖尿病患者,餐前胰岛素类型、运动时机与餐后运动诱导性低血糖风险之间的关系尚不清楚。我们旨在评估运动时机(餐后 60 分钟与 120 分钟)和不同胰岛素类型(门冬胰岛素与超速效门冬胰岛素)对低血糖风险的影响。

方法

这是一项四交叉随机对照试验,纳入了 40 名使用多次每日注射(平均 HbA 56mmol/mol[7.4%])的 1 型糖尿病患者。参与者从蒙特利尔临床研究所招募,在早餐后进行 60 分钟的自行车运动(60%[EX60min]或 120 分钟[EX120min]),并使用 50%的常规胰岛素剂量(门冬胰岛素或超速效门冬胰岛素)。入选标准包括年龄≥18 岁、临床诊断为 1 型糖尿病至少 1 年且 HbA≤80mmol/mol(9.5%)。使用顺序编号、不透明密封信封进行分组。参与者对分组情况不知情,且每位参与者都被分配了一个唯一的识别号以确保匿名。主要结局指标是运动起始至血糖最低点之间的血糖变化。

结果

在运动开始前,EX60min 组的高血糖时间比例低于 EX120min 组(血糖>10.0mmol/l:56.6%[1.2-100%] vs 78.0%[52.7-97.9%];p<0.001)。EX60min 组与 EX120min 组相比,运动起始至血糖最低点之间的血糖降低幅度较小(-3.8±2.7mmol/l 与-4.7±2.5mmol/l;p<0.001)。两种运动时间都发生了相似数量的低血糖事件。与门冬胰岛素相比,超速效门冬胰岛素使运动起始至血糖最低点之间的血糖降低幅度更小(-4.1±2.3mmol/l 与-4.4±2.8mmol/l;p=0.037)。尽管在运动期间观察到了相似数量的低血糖事件,但超速效门冬胰岛素后发生的低血糖事件较少(运动后无低血糖事件,0%,vs 运动后低血糖事件,15%,38%;p=0.003)。未发现胰岛素类型和运动时间之间存在相互作用。

结论/解释:EX60min 可减弱早餐后餐前血糖升高,且与运动期间血糖降低幅度较小有关。超速效门冬胰岛素可使运动期间的血糖降低幅度更小,且可能与运动后低血糖的发生减少有关。

临床试验注册

ClinicalTrials.gov NCT03659799 资助:本研究由 Novo Nordisk Canada 资助。

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