Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Plasma glucose
研究概览
简要总结
Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Psychological stress levels are assessed from Competitive State Anxiety Inventory-2.
The athletes are studied on two occasions: Day 1: 5K running competition and Day 2: 5K high intensity training session (running) in the athletes' regular training environment.
Endpoints Primary endpoints: Change in plasma glucose from start of exercise to end of exercise during competition compared to training.
Secondary endpoints: Hormonal response (cortisol, adrenalin, noradrenaline). Changes in heart rate and HRV before, during and after exercise. CGM-glucose and plasma glucose discrepancies.
详细描述
Design 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study.
Screening visit Investigator Rakel Fuglsang Johansen will orally inform eligible athletes about the study at the screening visit at Steno Diabetes Center Aarhus. Individuals who have agreed to join the study (given oral and written informed consent), will have a short physically examination performed including measurement of blood pressure, height, weight, and heart and lung auscultation and screening blood samples (kidney, liver, and blood counts, lipids, and HbA1c) will be taken.
Prior to study days Within 1 month prior to the 1st study day, eligible participants will also be invited to perform a maximal incremental test to volitional exhaustion to determine their individual VO2 max. The test will be performed on a treadmill.
The athletes come to the outpatient clinic 2 days prior to the 1st study day (training or competition), where they are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Instructions on food and liquid intake prior to study days are provided.
The participants are required to refrain from any intense or prolonged physical activity and alcohol consumption 48 hours prior to study days and instructed to consume a weight maintaining diet according to recommended guidelines (approx. 20 % fat, 30 % protein and 50 % carbohydrate). The participants are asked to keep a food diary and to match their food intake as accurate as possible before the two study days.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •T1D and healthy athletes who are otherwise healthy
- •Age between 18 and 65 years
- •HbA1c less than 70 mmol/mol
- •The athletes must be engaged in competitive sports that includes running, and agree to participate in a local 5 km running competition within 3 months
排除标准
- •Proliferative retinopathy
- •Hypoglycemia unawareness
- •Heart disease and other conditions which may be negatively affected by the VO2 max test and study days
研究组 & 干预措施
Competition
Participation in a 5 K competition (running)
干预措施: 5 K running (Other)
Training
Performing a 5 K up-tempo training bout (running)
干预措施: 5 K running (Other)
结局指标
主要结局
Plasma glucose
时间窗: Plasma glucose is measured Twenty minutes before the start of the competition until 60 minutes after the competition.
Change in plasma glucose from start of exercise to end of exercise during competition compared to training. Level of plasma glucose at the beginning and end of competition versus training session.
次要结局
未报告次要终点