Type 1 Diabetes Mellitus, Diabetes Complications
Conditions
Keywords
Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFructose
Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
OTHERPlain water
Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose levels during exercise | From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia | Plasma glucose will be measured repeatedly every 5 minutes |
| Glucose levels after exercise | From time point 0 minutes until time point 90 minutes | Plasma glucose will be measured repeatedly every 5 minutes |
| Lactate levels before exercise | From time point -30 minutes until time point 0 minutes (initiation of exercise) | Lactate will be measured repeatedly every 5 minutes |
| Lactate levels during exercise | From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia | Lactate will be measured repeatedly every 5 minutes |
| Lactate levels after exercise | From time point 0 minutes until time point 90 minutes | Lactate will be measured repeatedly every 5 minutes |
| Insulin levels before exercise | Time point -30 minutes until time point 0 minutes (initiation of exercise) | Lactate will be measured repeatedly every 15 minutes |
| Insulin levels during exercise | From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia | Insulin will be measured repeatedly every 15 minutes |
| Glucose levels before exercise | Time point -30 minutes until time point 0 minutes (initiation of exercise) | Plasma glucose will be measured repeatedly every 5 minutes |
| Heart rate before exercise | Time point -30 minutes until time point 0 minutes (initiation of exercise) | Heart rate will be measured using an electro-cardio-gramme |
| Heart rate during exercise | From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia | Heart rate will be measured using an electro-cardio-gramme |
| Oxygen consumption before exercise | Between 15 minutes and 5 minutes before initiation of exercise | Oxygen consumption will be measured via spirometry |
| Oxygen consumption during exercise | Between 15 minutes and 20 minutes during exercise | Oxygen consumption will be measured via spirometry |
| Carbon dioxide production before exercise | Between 15 minutes and 5 minutes before initiation of exercise | Carbon dioxide production will be measured via spirometry |
| Carbon dioxide production during exercise | Between 15 minutes and 20 minutes during exercise | Carbon dioxide production will be measured via spirometry |
| Insulin levels after exercise | From time point 0 minutes until time point 150 minutes | Insulin will be measured repeatedly every 15 minutes |
Countries
Switzerland
Outcome results
None listed