NCT02635269Unknown不适用
Fat and Sugar Metabolism During Exercise in Patients With Metabolic Myopathy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total fat oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.
研究概览
简要总结
This study aims to characterize the pathophysiological mechanisms of 21 different metabolic myopathies. The study will focus on exercise capacity and the metabolic derangement during exercise.
详细描述
Patients will be compared to a group of matched healthy control subjects (matched for age, gender, physical activity level and BMI) for comparison of the primary and secondary outcome measures.
Methods:
Each subject will go through 3 test days.
Test day 1:
- International Physical Activity Questionnaire (IPAQ). The results will be used to match the patients to control subjects.
- DEXA-scan. This is used to estimate the volume of distribution for stable isotope tracers.
- Maximal oxidative capacity test (max-test). On a cycle ergometer, subjects will exercise for approximately 15 minutes with increasing resistance until exhaustion. The peak oxidative and workload capacities will be compared to the healthy controls and will be used to find the workload that corresponds to 55-65 % of VO2max used in the following exercise tests.
- Blood samples. Samples will be drawn before exercise and at exhaustion and will be analyzed for the plasma concentrations of glucose, lactate, ammonia, creatine kinase and myoglobin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with genetically and/or biochemically verified LCHAD Deficiency
- •Healthy controls needs to be healthy to be included, evaluated by the investigator.
排除标准
- •Competing conditions at risk of compromising the results of the study.
- •Pregnancy or breastfeeding
- •Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise.
- •Inability to understand the purpose of the trial or corporate for the conduction of the experiments.
- •Veins that are too difficult to puncture for blood sampling or insertion of intravenous catheters, evaluated by the investigator
- •Moderate to severe muscle weakness, that prevents the subject completing 10 minutes of cycle-ergometry exercise at 60-70 % of VO2peak, evaluated by the investigator.
- •Participation in other trials that may interfere with the results.
- •Intake of medications that may interfere with the results or may compromise exercise performance, as evaluated by the investigators.
- •Donation of blood within 30 days prior to conduction of the tests on test day 1.
研究组 & 干预措施
Sugar
Experimental
The subjects exercise on the cycle-ergometer until exhaustion or for a maximum of 1 hour at an intensity that corresponds to 60-65% of VO2max.
干预措施: Sugar (Other)
结局指标
主要结局
Total fat oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.
时间窗: Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation
Measured using stable isotope technique (\[U-13C\]-palmitate, \[1,1,2,3,3-2H5\]-glycerol and \[6.6-2H2\]-glucose ) and indirect calorimetry.
次要结局
- Maximal oxidative capacity (mL*kg-1*minutes-1)(Day 1 of participation)
- Self-evaluated exertion (Rate of Perceived Exertion (RPE)) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured using a Borg-scale (6-20).(During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.)
- Oxygen consumption rate (VO2) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured in mL.(During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.)
- Total glucose oxidation (rate of disappearance) during prolonged moderate intensity exercise. Measured as micro mol per kg per minute.(Measured at at time (minutes) -120, -20, -10, 0, 10, 20, 30, 40, 50, 60. Zero is the indicatet start of 1 hour cycling test. Measured on day 2 of participation)
- Heart rate (HR) during prolonged exercise, with and without blood sugar maintained by an infusion of a 10% glucose solution. Measured in beats per minute.(During 1 hour cycling test 1 and 1 hour cycling test 2 on day 2 and 4 of participation.)
- Maximal workload capacity. Measured in watt(Day 1 of participation)
- Endurance measured as minutes:seconds(Day 2 and 4 of participation)
研究者
Karen Lindhardt Madsen
MD
Rigshospitalet, Denmark
研究点 (2)
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