Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT05357534
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2022-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood sugar', 'timeFrame': 'Day 0', 'description': 'Blood sugar evaluated in g/L via continuous blood glucose measurement'}, {'measure': 'Feeling lucidity', 'timeFrame': 'Day 0', 'description': 'Lucidity, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "not at all lucid" to "completely lucid"'}, {'measure': 'Feeling fatigue', 'timeFrame': 'Day 0', 'description': 'hydratation, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of dehydration" to "dehydrated"'}, {'measure': 'feeling hungry', 'timeFrame': 'Day 0', 'description': 'hungry, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of hunger" to "hungry"'}, {'measure': 'average speed per kilometer Sports performance', 'timeFrame': 'Day 0', 'description': 'Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill'}, {'measure': 'total running time', 'timeFrame': 'Day 0', 'description': 'Sports performance evaluated by total running time of the 10 km run on a treadmill'}, {'measure': 'average running speed', 'timeFrame': 'Day 0', 'description': 'Sports performance evaluated by average running speed of the 10 km run on a treadmill'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'blood sugar variations', 'physical activity'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity.\n\nSports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. However, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia.\n\nMoreover, hypoglycemia and hyperglycemia will impact body functions. Perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.', 'detailedDescription': 'The aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetics diagnosed more than 3 years ago and controlled (an HbA1c of less than 8%) for "type 1 diabetes" group\n* without diabetes for "healkthy" group\n* Male\n* Aged 18 to 65\n* Body Mass Index less than 30 kg/m2\n* regular running (at least 30 minutes per week and at least one 10-km run per year for the previous 2 years)\n* Agreeing to participate in the study\n\nExclusion Criteria:\n\n* Physical injury\n* beta blockers treatment'}, 'identificationModule': {'nctId': 'NCT05357534', 'acronym': 'GLYSPORT', 'briefTitle': 'Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients', 'orgStudyIdInfo': {'id': '2022-RIPH_002_GLYSPORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Type 1 diabetes" group', 'description': '"type 1 diabetes" group: patients with type 1 diabetes', 'interventionNames': ['Other: Physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': '"healthy" group', 'description': '"healthy" group : subjects without type 1 diabetes', 'interventionNames': ['Other: Physical activity']}], 'interventions': [{'name': 'Physical activity', 'type': 'OTHER', 'description': 'Physical activity: 10 km run on a treadmill', 'armGroupLabels': ['"Type 1 diabetes" group', '"healthy" group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Philippe JOLY, MCU-HDR', 'role': 'CONTACT', 'email': 'philippe.joly@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}, {'name': 'Coralie BARBE, MD', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}