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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital
Bern, Switzerland
Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)
The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.
Time frame: From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia
Glucose levels before exercise
Plasma glucose will be measured repeatedly every 5 minutes
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Glucose levels during exercise
Plasma glucose will be measured repeatedly every 5 minutes
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Glucose levels after exercise
Plasma glucose will be measured repeatedly every 5 minutes
Time frame: From time point 0 minutes until time point 90 minutes
Lactate levels before exercise
Lactate will be measured repeatedly every 5 minutes
Time frame: From time point -30 minutes until time point 0 minutes (initiation of exercise)
Lactate levels during exercise
Lactate will be measured repeatedly every 5 minutes
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Lactate levels after exercise
Lactate will be measured repeatedly every 5 minutes
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Time frame: From time point 0 minutes until time point 90 minutes
Insulin levels before exercise
Lactate will be measured repeatedly every 15 minutes
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Insulin levels during exercise
Insulin will be measured repeatedly every 15 minutes
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Insulin levels after exercise
Insulin will be measured repeatedly every 15 minutes
Time frame: From time point 0 minutes until time point 150 minutes
Heart rate before exercise
Heart rate will be measured using an electro-cardio-gramme
Time frame: Time point -30 minutes until time point 0 minutes (initiation of exercise)
Heart rate during exercise
Heart rate will be measured using an electro-cardio-gramme
Time frame: From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia
Oxygen consumption before exercise
Oxygen consumption will be measured via spirometry
Time frame: Between 15 minutes and 5 minutes before initiation of exercise
Oxygen consumption during exercise
Oxygen consumption will be measured via spirometry
Time frame: Between 15 minutes and 20 minutes during exercise
Carbon dioxide production before exercise
Carbon dioxide production will be measured via spirometry
Time frame: Between 15 minutes and 5 minutes before initiation of exercise
Carbon dioxide production during exercise
Carbon dioxide production will be measured via spirometry
Time frame: Between 15 minutes and 20 minutes during exercise