Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec
- Conditions
- Type 1 Diabetes MellitusDiabetes Complications
- Interventions
- Dietary Supplement: FructoseOther: Plain water
- Registration Number
- NCT03497260
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fructose in water first, water only second Fructose 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 Fructose in water first, water only second Plain water 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 Water only first, Fructose in water second Plain water 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 Water only first, Fructose in water second Fructose 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
Insulin levels after exercise From time point 0 minutes until time point 150 minutes Insulin will be measured repeatedly every 15 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
Trial Locations
- Locations (1)
Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital
🇨ðŸ‡Bern, Switzerland