Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03497260
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2018-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005632', 'term': 'Fructose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2018-04-06', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (in minutes) to hypoglycaemia (plasma glucose <3.9mmol/l)', 'timeFrame': 'From time point 0 minutes (initiation of exercise) to time point 60 minutes (completion of exercise) or development of hypoglycaemia', 'description': 'The development of hypoglycaemia will be determined by repeated measurement of plasma glucose.'}], 'secondaryOutcomes': [{'measure': 'Glucose levels before exercise', 'timeFrame': 'Time point -30 minutes until time point 0 minutes (initiation of exercise)', 'description': 'Plasma glucose will be measured repeatedly every 5 minutes'}, {'measure': 'Glucose levels during exercise', 'timeFrame': 'From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia', 'description': 'Plasma glucose will be measured repeatedly every 5 minutes'}, {'measure': 'Glucose levels after exercise', 'timeFrame': 'From time point 0 minutes until time point 90 minutes', 'description': 'Plasma glucose will be measured repeatedly every 5 minutes'}, {'measure': 'Lactate levels before exercise', 'timeFrame': 'From time point -30 minutes until time point 0 minutes (initiation of exercise)', 'description': 'Lactate will be measured repeatedly every 5 minutes'}, {'measure': 'Lactate levels during exercise', 'timeFrame': 'From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia', 'description': 'Lactate will be measured repeatedly every 5 minutes'}, {'measure': 'Lactate levels after exercise', 'timeFrame': 'From time point 0 minutes until time point 90 minutes', 'description': 'Lactate will be measured repeatedly every 5 minutes'}, {'measure': 'Insulin levels before exercise', 'timeFrame': 'Time point -30 minutes until time point 0 minutes (initiation of exercise)', 'description': 'Lactate will be measured repeatedly every 15 minutes'}, {'measure': 'Insulin levels during exercise', 'timeFrame': 'From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia', 'description': 'Insulin will be measured repeatedly every 15 minutes'}, {'measure': 'Insulin levels after exercise', 'timeFrame': 'From time point 0 minutes until time point 150 minutes', 'description': 'Insulin will be measured repeatedly every 15 minutes'}, {'measure': 'Heart rate before exercise', 'timeFrame': 'Time point -30 minutes until time point 0 minutes (initiation of exercise)', 'description': 'Heart rate will be measured using an electro-cardio-gramme'}, {'measure': 'Heart rate during exercise', 'timeFrame': 'From time point 0 minutes until time point 60 minutes (completion of exercise) or development of hypoglycaemia', 'description': 'Heart rate will be measured using an electro-cardio-gramme'}, {'measure': 'Oxygen consumption before exercise', 'timeFrame': 'Between 15 minutes and 5 minutes before initiation of exercise', 'description': 'Oxygen consumption will be measured via spirometry'}, {'measure': 'Oxygen consumption during exercise', 'timeFrame': 'Between 15 minutes and 20 minutes during exercise', 'description': 'Oxygen consumption will be measured via spirometry'}, {'measure': 'Carbon dioxide production before exercise', 'timeFrame': 'Between 15 minutes and 5 minutes before initiation of exercise', 'description': 'Carbon dioxide production will be measured via spirometry'}, {'measure': 'Carbon dioxide production during exercise', 'timeFrame': 'Between 15 minutes and 20 minutes during exercise', 'description': 'Carbon dioxide production will be measured via spirometry'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes, Fructose, Exercise, Hypoglycaemia, Degludec'], 'conditions': ['Type 1 Diabetes Mellitus', 'Diabetes Complications']}, 'referencesModule': {'references': [{'pmid': '32591421', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAs 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Male subjects aged between 18-45 years\n* HbA1c \\<8.0% (64mmol/mol) based on analysis from the central laboratory unit of the University Hospital Bern.\n* Basal/Bolus-insulin regimen with insulin degludec for at least 3 months, with good knowledge of insulin self-management\n* Regular physical activity (at least 30 min of moderate exercise 3 times weekly)\n* Written informed consent\n\nExclusion Criteria:\n\n* Relevant diabetic complications as judged by the investigator\n* Total daily insulin dose \\>2 IU/kg/day\n* Hypoglycaemia unawareness (Gold score \\> 4) or any episode of severe hypoglycaemia as defined by the American Diabetes Association within the last 6 months\n* 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\n* Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, statins etc.\n* Known fructose-intolerance or malabsorption\n* Known allergy to one of the study drugs'}, 'identificationModule': {'nctId': 'NCT03497260', 'acronym': 'FruDeg', 'briefTitle': 'Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Fructose to Reduce Exercise-associated Hypoglycaemia in Individuals With Type 1 Diabetes Treated With Insulin Degludec: Questioning a Paradigm and Offering a Novel Strategy', 'orgStudyIdInfo': {'id': 'FruDeg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fructose in water first, water only second', 'description': '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', 'interventionNames': ['Dietary Supplement: Fructose', 'Other: Plain water']}, {'type': 'EXPERIMENTAL', 'label': 'Water only first, Fructose in water second', 'description': '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', 'interventionNames': ['Dietary Supplement: Fructose', 'Other: Plain water']}], 'interventions': [{'name': 'Fructose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.', 'armGroupLabels': ['Fructose in water first, water only second', 'Water only first, Fructose in water second']}, {'name': 'Plain water', 'type': 'OTHER', 'description': 'Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.', 'armGroupLabels': ['Fructose in water first, water only second', 'Water only first, Fructose in water second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Christoph Stettler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselspital, Bern University Hospital, University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}