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Ex-Timing 试验:评估 2 型糖尿病合并超重/肥胖个体生物钟中晨练、午练和晚练的随机交叉研究方案。

The Ex-Timing trial: evaluating morning, afternoon, and evening exercise on the circadian clock in individuals with type 2 diabetes and overweight/obesity-a randomized crossover study protocol.

机构信息

Exercise and Health Laboratory, CIPER, Faculdade Motricidade Humana, Universidade Lisboa, Estrada da Costa, Cruz-Quebrada, 1499-688, Portugal.

Hospital de Santa Cruz, Centro Hospitalar Lisboa Ocidental, Departamento de Reabilitação Cardíaca, Lisbon, Portugal.

出版信息

Trials. 2024 Aug 6;25(1):526. doi: 10.1186/s13063-024-08335-y.

DOI:10.1186/s13063-024-08335-y
PMID:39107793
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11301977/
Abstract

BACKGROUND

Exercise is known to provide multiple metabolic benefits such as improved insulin sensitivity and glucose control in individuals with type 2 diabetes mellitus (T2DM) and those at risk. Beyond the traditional exercise dose, exercise timing is perceived as a contemporary hot topic, especially in the field of T2DM; however, the number of intervention studies assessing exercise timing and glucose metabolism is scarce. Our aim is to test the effect of exercise timing (i.e., morning, afternoon, or evening) on the inter-individual response variability in glycemic control and related metabolic health parameters in individuals with T2DM and those at risk during a 12-week intervention.

METHODS

A randomized crossover exercise intervention will be conducted involving two groups: group 1, individuals with T2DM; group 2, age-matched older adults with overweight/obesity. The intervention will consist of three 2-week blocks of supervised post-prandial exercise using high-intensity interval training (HIIT). Between each training block, a 2-week washout period, where participants avoid structured exercise, will take place. Assessments will be conducted in both groups before and after each exercise block. The primary outcomes include the 24-h area under the curve continuous glucose monitoring-based glucose. The secondary outcomes include body composition, resting energy expenditure, insulin response to a meal tolerance test, maximal aerobic capacity, peak power output, physical activity, sleep quality, and insulin and glucose levels. All primary and secondary outcomes will be measured at each assessment point.

DISCUSSION

Outcomes from this trial will provide us additional insight into the role of exercise timing on the inter-individual response variability in glycemic control and other related metabolic parameters in two distinct populations, thus contributing to the development of more effective exercise prescription guidelines for individuals with T2DM and those at risk.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06136013. Registered on November 18, 2023.

摘要

背景

运动被认为能为 2 型糖尿病(T2DM)患者和高危人群提供多种代谢益处,如改善胰岛素敏感性和血糖控制。除了传统的运动剂量外,运动时间被认为是一个当代热门话题,尤其是在 T2DM 领域;然而,评估运动时间和葡萄糖代谢的干预研究数量很少。我们的目的是在 12 周的干预期间,测试运动时间(即早上、下午或晚上)对 T2DM 患者和高危人群血糖控制的个体间反应变异性及相关代谢健康参数的影响。

方法

将进行一项随机交叉运动干预,涉及两组:组 1,T2DM 患者;组 2,年龄匹配的超重/肥胖老年人。干预将包括三个 2 周的餐后监督高强度间歇训练(HIIT)。在每个训练块之间,将进行 2 周的洗脱期,参与者在此期间避免进行结构化运动。在每个运动块前后,将对两组进行评估。主要结果包括基于连续血糖监测的 24 小时曲线下面积葡萄糖。次要结果包括身体成分、静息能量消耗、餐耐量试验胰岛素反应、最大有氧能力、最大功率输出、身体活动、睡眠质量以及胰岛素和血糖水平。所有主要和次要结果将在每个评估点进行测量。

讨论

该试验的结果将为我们提供更多的信息,了解运动时间对两种不同人群血糖控制及其他相关代谢参数的个体间反应变异性的作用,从而为制定更有效的 T2DM 患者和高危人群的运动处方指南做出贡献。

试验注册

ClinicalTrials.gov NCT06136013。注册于 2023 年 11 月 18 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e13/11301977/f0449cbbdf3f/13063_2024_8335_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e13/11301977/5495fd51ff3d/13063_2024_8335_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e13/11301977/f0449cbbdf3f/13063_2024_8335_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e13/11301977/5495fd51ff3d/13063_2024_8335_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e13/11301977/f0449cbbdf3f/13063_2024_8335_Fig2_HTML.jpg

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