cArdiopulmonary exerCise Test Assessing Multiple biOmarkers and Hormones iN Type 1 diabetEs Under Different Circumstances (ACT-ONE)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- CGM outcomes during and after morning exercise
研究概览
简要总结
Collection of venous blood samples in 50 persons with type 1 diabetes to evaluate the behavior of different biomarkers (glucose, lactate, beta-hydroxybutyrate), and hormones (cortisol, growth hormone) during and after one morning CardioPulmonary Exercise Test and 2 aerobic (90 minutes at 40-45% of VO2 max) exercise tests under different circumstances (see Protocol).
详细描述
This study is an extension of the Action-1 pilot study. This study is an extension of the Action-1 pilot study. The aim is to collect samples of multiple biomarkers (circulating glucose, ketones and lactate levels) and hormones (cortisol and growth hormone) during and following an anaerobic and two aerobic exercise in patients with T1D, under more and well-defined circumstances (bolus insulin reduction in combination with major vs. minor basal insulin reduction) to aim for safer glucose levels during and after exercise (~90-180 mg/dL or ~5-10 mmol/L) and avoid extreme glucose excursions to hypo (< 70 mg/dL or <3.9 mmol/L) or hyperglycemia (>180 mg/dL or >10 mmol/L). Based on these data, we aim to formulate exercise guidelines to better help prevent hypoglycemia during and after exercise. Overall, our goal is to help maintain target glycemic values during and after exercise, as evidenced by >70% time in range (70-180mg/dL) while using Continuous Glucose Monitoring (CGM).
Primary endpoint:
• CGM outcomes during and after morning exercise, determined as:
- Time in range (TIR) 70-180mg/dL
- Time below range (TBR) Level 2, <54 mg/dL
- Time below range (TBR) Level 1 and 2, <70 mg/dL
- Time above range (TAR) Level 1 and 2, >180 mg/dL
- Time above range (TAR) Level 2, >250 mg/dL
Secondary endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Duration of type 1 diabetes mellitus >5y
- •Subjects willing to sign an informed consent form (ICF)
- •Age 18-60y
- •Using a continuous glucose monitoring system (preferably Guardian or Dexcom for CSII / Freestyle Libre for MDI)
- •For CSII: only hybrid closed loop pumps (HCL)
- •For MDI: only Tresiba (degludec) & Toujeo (glargine)
- •HbA1c 6-8.0% (blood result up to 3 months old)
- •BMI 20-27.5 kg/m2
- •The participant should be in the categories 'moderately' to 'highly physically active' according to the IPAQ score
- •The Physical Activity Coefficient has not changed (from category1) in the 2 months prior to the first Exercise Test
排除标准
- •Being pregnant or having an active pregnancy wish
- •Subject not on MDI or CSII
- •Musculoskeletal disorder that affects cycling or is a contra-indication for vigorous physical activity
- •Cardiorespiratory disease or ECG abnormality that is a contra-indication for vigorous physical activity
- •Having an acute illness (e.g. influenza) that interferes with glucose metabolism
- •Having a metabolic disorder (different from diabetes) known to have significant interference with glucose metabolism
- •Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
- •Presence of concomitant pathology such as heart failure, liver failure, kidney failure (defined as eGFR <45mL/min, blood result up to 12 months old)
- •(Severe) food allergies as judged by the investigator
结局指标
主要结局
CGM outcomes during and after morning exercise
时间窗: CGM values will be collected up to 8 hours prior to the exercise test and 24 hours after the exercise test
CGM outcomes, determined as: * Time in range (TIR) 70-180mg/dL * Time below range (TBR) Level 2, \<54 mg/dL * Time below range (TBR) Level 1 and 2, \<70 mg/dL * Time above range (TAR) Level 1 and 2, \>180 mg/dL * Time above range (TAR) Level 2, \>250 mg/dL
次要结局
- Change in glucose concentration in venous blood during and after morning exercise test(Blood sampling was done before the exercise, every 3-10 minutes during the exercise and every 15 minutes during the first hour of recovery and every 30-60 minutes during the rest of the 6-hour follow-up)
- Change in ketone concentration in venous blood during and after morning exercise test(Blood sampling was done before the exercise, every 3-10 minutes during the exercise and every 15 minutes during the first hour of recovery and every 30-60 minutes during the rest of the 6-hour follow-up)
- Change in growth hormone concentration in venous blood during and after morning exercise test(Blood sampling was done before the exercise, every 15-30 minutes during the exercise and every 15-30 minutes during the first hour of recovery and every 60-120 minutes during the rest of the 6-hour follow-up)
- Change in lactate concentration in venous blood during and after morning exercise test(Blood sampling was done before the exercise, every 3-10 minutes during the exercise and every 15 minutes during the first hour of recovery and every 30-60 minutes during the rest of the 6-hour follow-up)
- Change in cortisol concentration in venous blood during and after morning exercise test(Blood sampling was done before the exercise, every 15-30 minutes during the exercise and every 15-30 minutes during the first hour of recovery and every 60-120 minutes during the rest of the 6-hour follow-up)