Fructose to Reduce Exercise-associated Hypoglycaemia in Individuals With Type 1 Diabetes Treated With Insulin Degludec: Questioning a Paradigm and Offering a Novel Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)
研究概览
简要总结
To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load.
详细描述
Glycaemic control remains complex and demanding during exercise for type 1 diabetes (T1D) patients. Traditional treatment guidelines for exercise emphasizing the reduction of insulin doses and/or ingestion of additional carbohydrates are of limited applicability for patients treated with ultra-long acting basal insulin analogues. Dose reductions may require two to three days for modern basal insulin analogues in order to achieve an adapted steady state, hereby increasing the risk of inadequate insulin-following exercise. If T1D patients engage in recreational exercise - as recommended by every international treatment guideline - current treatment strategies may simply not be sufficient.
As a consequence for patients treated with modern basal insulin analogues, it seems more adequate not to modify insulin doses but to apply alternative strategies for recreational exercise. The ingestion of fructose, an insulin-independent carbohydrate, which increases lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. Up to date, only preliminary data for fructose have been produced regarding clinical effectiveness and underlying mechanisms in the prevention of hypoglycaemia. The present comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a pre-exercise oral fructose load without modification of insulin degludec in T1D patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes as defined by the World Health Organization (WHO) for at least 1 year or confirmed negative C-peptide (<100pmol/l with concomitant blood glucose >4 mmol/l)
- •Male subjects aged between 18-45 years
- •HbA1c <8.0% (64mmol/mol) based on analysis from the central laboratory unit of the University Hospital Bern.
- •Basal/Bolus-insulin regimen with insulin degludec for at least 3 months, with good knowledge of insulin self-management
- •Regular physical activity (at least 30 min of moderate exercise 3 times weekly)
- •Written informed consent
排除标准
- •Relevant diabetic complications as judged by the investigator
- •Total daily insulin dose >2 IU/kg/day
- •Hypoglycaemia unawareness (Gold score > 4) or any episode of severe hypoglycaemia as defined by the American Diabetes Association within the last 6 months
- •Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- •Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, statins etc.
- •Known fructose-intolerance or malabsorption
- •Known allergy to one of the study drugs
研究组 & 干预措施
Water only first, Fructose in water second
Intake of 200 ml of tap water at first visit; intake of 200 ml of 20 g of fructose dissolved in 200 ml of tap water at second visit
干预措施: Plain water (Other)
Fructose in water first, water only second
Intake of 20 g of fructose dissolved in 200 ml of tap water at first visit; intake of 200 ml of tap water at second visit
干预措施: Plain water (Other)
Fructose in water first, water only second
Intake of 20 g of fructose dissolved in 200 ml of tap water at first visit; intake of 200 ml of tap water at second visit
干预措施: Fructose (Dietary Supplement)
Water only first, Fructose in water second
Intake of 200 ml of tap water at first visit; intake of 200 ml of 20 g of fructose dissolved in 200 ml of tap water at second visit
干预措施: Fructose (Dietary Supplement)
结局指标
主要结局
Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)
时间窗: From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia
The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.
次要结局
- Glucose levels after exercise(From time point 0 minutes until time point 90 minutes)
- Lactate levels before exercise(From time point -30 minutes until time point 0 minutes (initiation of exercise))
- Lactate levels during exercise(From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia)
- Lactate levels after exercise(From time point 0 minutes until time point 90 minutes)
- Glucose levels before exercise(Time point -30 minutes until time point 0 minutes (initiation of exercise))
- Glucose levels during exercise(From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia)
- Insulin levels before exercise(Time point -30 minutes until time point 0 minutes (initiation of exercise))
- Insulin levels during exercise(From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia)
- Insulin levels after exercise(From time point 0 minutes until time point 150 minutes)
- Heart rate before exercise(Time point -30 minutes until time point 0 minutes (initiation of exercise))
- Heart rate during exercise(From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia)
- Oxygen consumption before exercise(Between 15 minutes and 5 minutes before initiation of exercise)
- Oxygen consumption during exercise(Between 15 minutes and 20 minutes during exercise)
- Carbon dioxide production before exercise(Between 15 minutes and 5 minutes before initiation of exercise)
- Carbon dioxide production during exercise(Between 15 minutes and 20 minutes during exercise)