cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
研究概览
简要总结
Collection of venous blood samples in male T1D patients to evaluate the behavior of different biomarkers (beta-hydroxybutyrate, lactate, glucose) during and after morning Aerobic (60% of VO2 max) and Symptom Limited Maximal Exercise Test.
详细描述
Compare values and trends of different biomarkers (glucose, lactate and beta-hydroxybutyrate) before, during and after morning aerobic and symptom limited maximal exercise (cycling) to predict glycemic fluctuations (hypo- and hyperglycemic events) during and after exercise in order to create treatment algorithms to prevent these events.
Endpoint:
• Evaluate values and trends of glucose, lactate and beta-hydroxybutyrate before, during and after morning exercise in venous blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male adults (18-40 years old) with T1D, diagnosed since > 1 year
- •Using a CGM (Dexcom G5) or willing to wear a CGM (Dexcom G5) for the duration of the study.
- •The CGM must be applied >48h before the exercise test
- •Participants are on intensified insulin therapy (MDI) or insulin pump therapy (CSII)
- •6% ≤ HbA1c ≤ 8%
- •Having a self-reported moderate activity level on the iPAQ (Internationally Physical Activity Questionnaire).
- •C-peptide <0.2 nmol/l
- •The Physical Activity Coefficient has not changed in the 2 months prior to the first Exercise Test.
- •20kg/m2 < BMI < 25kg/m2
排除标准
- •Recently diagnosed T1D (< 12mo)
- •Participants 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) or takes drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
- •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
- •Patient not able or willing to sign the patient informed consent
结局指标
主要结局
Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
时间窗: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Glucose levels in mg/dL during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX \& CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
Change in lactate concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
时间窗: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Lactate levels in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX \& CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
Change in ketone concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
时间窗: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Ketone levels (Beta-hydroxybutyrate) in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX \& CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
次要结局
未报告次要终点
研究者
Christophe De Block
Prof Dr Christophe De Block, Head of the Department of Endocrinology, Diabetology and Metabolism, Principal Investigator, Clinical Professor
University Hospital, Antwerp