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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fructose in water first, water only second | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fructose | Dietary Supplement | Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l) | The development of hypoglycaemia will be determined by repeated measurement of plasma glucose. | From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose levels before exercise | Plasma glucose will be measured repeatedly every 5 minutes | Time point -30 minutes until time point 0 minutes (initiation of exercise) |
| Glucose levels during exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Stettler, MD | Inselspital, Bern University Hospital, University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32591421 | Derived | Kosinski C, Herzig D, Laesser CI, Nakas CT, Melmer A, Vogt A, Vogt B, Laimer M, Bally L, Stettler C. A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study. Diabetes Care. 2020 Sep;43(9):2010-2016. doi: 10.2337/dc19-2250. Epub 2020 Jun 26. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D048909 | Diabetes Complications |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005632 | Fructose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 |
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| Plain water | Other | Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise. |
|
Plasma glucose will be measured repeatedly every 5 minutes
| 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 | From time point 0 minutes until time point 90 minutes |
| Lactate levels before exercise | Lactate will be measured repeatedly every 5 minutes | 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 | 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 | From time point 0 minutes until time point 90 minutes |
| Insulin levels before exercise | Lactate will be measured repeatedly every 15 minutes | Time point -30 minutes until time point 0 minutes (initiation of exercise) |
| Insulin levels during exercise | Insulin will be measured repeatedly every 15 minutes | 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 | 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 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 | 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 | Between 15 minutes and 5 minutes before initiation of exercise |
| Oxygen consumption during exercise | Oxygen consumption will be measured via spirometry | Between 15 minutes and 20 minutes during exercise |
| Carbon dioxide production before exercise | Carbon dioxide production will be measured via spirometry | Between 15 minutes and 5 minutes before initiation of exercise |
| Carbon dioxide production during exercise | Carbon dioxide production will be measured via spirometry | Between 15 minutes and 20 minutes during exercise |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| Ketoses |