Impact of Eccentric Training Conducted in the Conditions of Normobaric Hypoxia, Normoxia and Creatine Supplementation on Metabolic Control, Muscle Strength Level, Maximum Oxygen Consumption (VO2max) in Patients With Type 1diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters
详细描述
People with type 1 diabetes benefit from training in normobaric hypoxia - the composition of the air in the training room is: 15.4% oxygen 84.7% nitrogen, which corresponds to hypoxia at an altitude of 2,500 m above sea level. Hypoxia leads to the production of HIF-1 (hypoxia-inducible transcription factor ), which is a regulator of the expression of many genes responsible for angiogenesis, muscle hypertrophy and glucose stability.
Before starting the10 - week training program all participants will undergo preliminary examination by a cardiologist during which echocardiography and ECG will be conducted. Then the incremental exercise test and muscle strength test will be performed to determine aerobic capacity (VO2max) and select individual weights to train for each participant.
Patients enrolled to the study will be randomly assigned to one of the following 2 groups (training under normoxia or hypoxia conditions) and subgroups (with and without supplementation of creatine).
Randomization will be carried out in blocks of 4 people.
Training sessions will take place with the assistance of a personal trainer in the Hypoxia Laboratory and the Muscle Strength and Power Laboratory of Academy of Physical Education in Katowice twice a week for 60 minutes for a period of 10 weeks. The subjects will complete the same eccentric training program with individually selected weights.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes of at least 10 years duration,
- •low physical activity,
- •BMI:20-31 kg/m2,
- •treated with multiple insulin injections (at least 4 daily) or insulin pump (continuous subcutaneous insulin infusion [CSII]),
- •negative ECG exercise test,
- •HbA1c ≤ 8,0%,
- •high knowledge about functional insulin therapy, carbohydrate counting and diabetes management during exercise,
- •experience in use of FreeStyleLibre2 (Flash Glucose Monitoring System, Abbott),
- •Informed consent to participate in research signed by enrolled subjects
排除标准
- •HbA1c > 8,0%,
- •advanced complications of diabetes [pre-proliferative or proliferative retinopathy, and previous laser therapy, microalbuminuria or overt nephropathy, autonomic neuropathy (including lack of elevated heart rate during physical activity)],
- •patients physically active (regular physical activities more than once a week),
- •positive ECG exercise test,
- •history of cardiovascular event or coronary heart disease
结局指标
主要结局
Time in range
时间窗: before and after 10 weeks
TIR- percentage of time with blood glucose in a target range: 70-180 mg/dl (%)
Time below range
时间窗: before and after 10 weeks
TBR - percentage of time with blood glucose levels\<70 mg/dl (%)
Maximum oxygen consumption (VO2max)
时间窗: before and after 10 weeks
measured during incremental exercise test
Metabolic control of diabetes
时间窗: before and after 10 weeks
HbA1c (%, mmol/mol)
次要结局
未报告次要终点