Inter- and Intraindividual Variability of the Acute Glucose Response to Exercise in Healthy Adults and People Living With Type 1 Diabetes: A Cross-over Replicate Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Interstitial glucose
研究概览
简要总结
The goal of this clinical trial is to investigate if blood glucose responses are similar between and within individuals in response to standardized exercise in adults with and without Type 1 diabetes. The main questions it aims to answer are:
What is the reproducibility of acute glycaemic responses to exercise within and between subjects in adults living with Type 1 Diabetes and in healthy adults? What is the agreement between glucose levels obtained by continuous glucose monitor (CGM) and blood glucose monitor?
Participants will cycle on a cycle ergometer or rest after consuming a standardized breakfast, while glucose levels are monitored by CGM and capillary blood sampling.
详细描述
This study follows a non-blinded randomized replicate crossover study design. The study involves two phases, one phase will involve participants with T1D and the other phase will involve healthy adults. The sample size will be approximately 12 in each phase. Both phases will follow the same protocol consisting of 2 arms (exercise (EX) and rest).
Participants will attend 5 visits in total in the laboratory. They will first undergo baseline assessments and maximal exercise testing before being randomized to receive either an exercise (EX) or resting (REST) condition at their visit first. The two visits will then repeated to assess reproducibility of the outcomes in the same order the following week (EX RE and REST RE). All test visits will be separated by a minimum washout period of 72 hours.
The first visit will last approximately 1 hour and involves signing informed consent, body composition assessment (BodPod), maximal exercise testing (Vo2 max) and completion of questionnaires.
Before each condition, participants are asked to refrain from strenuous physical activity and alcohol for at least 24 hours prior to the test(s). Prior to the first main testing day (either EX or RE based on randomization), participants are asked to record their dietary intake for 24h and asked to replicate it in the same period before the subsequent conditions.
Testing visits have a duration of 2 hours each. Participants will arrive at the laboratory after an overnight fast always at the same time in the morning (about 9am). While seated, baseline measurements will be collected, including 2 blood glucose measurements via finger prick, 2 CGM measurements, RPE, HR, measures of heart rate variability (HRV), and participants will the intensity of any hypoglycaemia-related symptoms using a Visual Analogue Scale (VAS). The same measurements will be repeated at regular intervals throughout the visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Healthy and T1D phases):
- •age between 18 and 60 years old;
- •being healthy individuals;
- •engagement in physical activity at least once a week; (T1D phase):
- •diagnosis of T1D for >18 months;
- •hypoglycaemia self awareness.
排除标准
- •(Healthy and T1D phases)
- •presence of cardiovascular disease or contraindications to exercise;
- •infectious or inflammatory conditions;
- •chronic renal or liver disease;
- •pregnancy;
- •gestational diabetes;
- •diagnosed eating disorders;
- •any physical or mental condition preventing participation; (Healthy phase)
- •diabetes mellitus (type 1 or type 2); (T1D phase)
- •inability to self-manage diabetes.
结局指标
主要结局
Interstitial glucose
时间窗: Over 2 hours: 2 samples at baseline in the fasted state before breakfast consumption; and every 5 minutes following breakfast for 2 hours.
Interstitial glucose values (mmol/l) collected via Freestyle libre 2 Continuous Glucose Monitor
Capillary glucose
时间窗: 2 hours: (1) at baseline before breakfast consumption; (2) every 10 minutes over 30 minutes after breakfast consumption during rest; (3) every 5 minutes for 30 minutes during cycle or seated rest based on intervention; (4) every 10 minutes for 60 min.
Capillary glucose was measured via finger prick using a blood glucose monitor.
次要结局
- Heart-rate variability(2 hours: (1) at baseline before breakfast consumption. (2) every 10 minutes for 120 minutes. (3) extra measurements of HR only were taken during the second thirty minutes, resulting in HR measurements at 5-minutes intervals during that time-frame.)
- Perception of symptoms of Hypoglycaemia.(2 hours: (1) at baseline before breakfast consumption; (2) every 20 minutes for 120 minutes.)
- Reporting of Perceived Exortion (RPE)(1 hour: (1) at baseline before breakfast consumption; (2) every 5 minutes during the second half hour.)