NCT05706298招募中不适用
The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in time in target glycaemic range
研究概览
简要总结
the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.
详细描述
An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D diagnosis more than 3 years ago
- •Sedentary (> 10h per waking day sedentary (sitting or lying)
- •Using insulin therapy with multiple daily injections or insulin pump
- •Aged 18-66 (UK retirement age)
- •Use of Abbot FreeStyle Libre 2 fGM (>6 weeks to avoid potential lifestyle changes as a result of sensor use)
排除标准
- •Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
- •Pregnancy or planning to become pregnant
- •<6 months postpartum or stopped breastfeeding <1 month before recruitment
- •Existing cerebrovascular or cardiovascular disease
- •Significant history of hyperglycaemia (HbA1c >85 mmol/mol)
- •History of severe hypoglycaemia requiring third party assistance within the last 3 months
结局指标
主要结局
Change in time in target glycaemic range
时间窗: change from baseline to final week of the intervention
flash glucose monitoring
次要结局
- Change in BMI(change from baseline to post intervention (4 weeks))
- Change in insulin dose(change from baseline to final week of the intervention)
- Change in waist circumference(change from baseline to post intervention (4 weeks))
- Change in glycaemic variability (coefficient of variation)(change from baseline to final week of the intervention)
- Change in Concentration of Hba1c(change from baseline to post intervention (4 weeks))
- Change in weight(change from baseline to post intervention (4 weeks))
- Change in sedentary behaviour(change from baseline to final week of the intervention)
- Change in Health-related quality of life(change from baseline to post intervention (4 weeks))
- Change in Anxiety and depression(change from baseline to post intervention (4 weeks))
- c-peptide(baseline)
- Change in carbohydrate intake(change from baseline to final week of the intervention)
- Change in Height(change from baseline to post intervention (4 weeks))
- Change Insulin to CHO ratio(change from baseline to post intervention (4 weeks))
- Change in Diabetes Quality of Life(change from baseline to post intervention (4 weeks))
- Change in triglycerides.(change from baseline to post intervention (4 weeks))
- Change in Insulin Sensitivity Score(change from baseline to post intervention (4 weeks))
研究者
研究点 (2)
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