Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT05540132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2022-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Slow Digestible Carbohydrates and Exercise in Adolescents with Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'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': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Within subject, randomized cross-over study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2022-09-10', 'studyFirstSubmitQcDate': '2022-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hypoglycemic events 12 hours after completion of exercise challenge', 'timeFrame': '12 hours after exercise challenge', 'description': 'Review of continuous glucose monitoring data'}, {'measure': 'Glycemic variability during exercise challenge', 'timeFrame': 'During exercise challenge', 'description': 'Review of continuous glucose monitoring data'}, {'measure': 'Time to completion of distance bike challenge', 'timeFrame': 'During exercise challenge', 'description': 'Number of minutes to complete 3.75 mile bike ride'}], 'secondaryOutcomes': [{'measure': 'Percent time spent in hypoglycemia following exercise challenge', 'timeFrame': '12 hours after exercise challenge', 'description': 'Review of continuous glucose monitoring data'}, {'measure': 'Percent time above range, in range, and below range following exercise challenge', 'timeFrame': '12 hours after exercise challenge', 'description': 'Review of continuous glucose monitoring data'}, {'measure': 'Glycemic variability in the 12 hours following the exercise test', 'timeFrame': '12 hours after exercise challenge', 'description': 'Review of continuous glucose monitoring data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent', 'exercise', 'cgm'], 'conditions': ['Type 1 Diabetes', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'In this within-subject cross-over study, the investigators hypothesize that corn-starch based supplements taken prior to exercise will decrease the risk of delayed hypoglycemia in adolescents with T1D, improve performance during exercise, and decrease glycemic variability during exercise.', 'detailedDescription': 'Type 1 diabetes (T1D), one of the most common chronic diseases in adolescents, is caused by the destruction of insulin producing beta cells which are located in the pancreas. There are many factors that impact diabetes control which are insulin administration, intake of food and exercise. When an individual exercises, weight is better managed which allows for a better cardiovascular system. Exercising also improves insulin sensitivity which can increased the risk for delayed hypoglycemia (low blood sugar). Many individuals with T1D do not participate (or under-participate) in exercise due to the fear of hypoglycemia. This study will recruit adolescents with Type 1 diabetes to undergo a maximal exercise test to determine their VO2max. Study participants then will complete 2 exercise performance tests prior to which the participant will be randomized to consume 22 grams of either fast acting carbohydrates or long-acting cornstarch based supplements. Subjects will be asked to bike for 45 minutes (at 50% of VO2max) and then complete a 3.75 mile bike ride as quickly as possible. The investigators will document the time to completion of the bike ride as well as monitor glucose levels via continuous glucose monitoring for 12 hours after completion of the exercise test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'genderBased': True, 'genderDescription': 'All genders are eligible, patients self-identification of gender will be recorded', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12 - \\<18 year old male and female subjects with Type 1 diabetes for \\> 1 year\n* HbA1c \\<10.5%\n* Body Mass Index \\>10th % and \\<95th%\n* Not being treated with sensor-augmented pump therapy\n* Ability to participate in exercise activity - biking\n* Willing to wear a continuous glucose monitor (CGM) sensor\n\nExclusion Criteria:\n\n* Severe hypoglycemia (requiring glucagon or external assistance) in last 6 months\n* Admission for diabetic ketoacidosis in last 3 months\n* History of chronic lung disease, congenital heart disease or chronic asthma\n* Food (including corn)/dye allergies\n* Other chronic medical conditions except for well-controlled thyroid disease'}, 'identificationModule': {'nctId': 'NCT05540132', 'briefTitle': 'Slow Digestible Carbohydrates and Exercise in Adolescents with Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Slow-digestible Carbohydrates Consumed Prior to Exercise Improve Performance and Decrease Risk of Delayed Hypoglycemia in Adolescents with Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'SS_T1D_2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fast Acting Carbohydrate', 'description': 'Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement', 'interventionNames': ['Dietary Supplement: maltodextrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Slow-acting cornstarch supplement', 'description': 'Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)', 'interventionNames': ['Dietary Supplement: super starch']}], 'interventions': [{'name': 'maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Pre-exercise carbohydrate, fast-acting', 'armGroupLabels': ['Fast Acting Carbohydrate']}, {'name': 'super starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Pre-exercise carbohydrate, slow-acting', 'armGroupLabels': ['Slow-acting cornstarch supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'UB MD Pediatrics Division of Pediatric Endocrinology', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Lucy Mastrandrea, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York at Buffalo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Data will become available June, 2024 and will be available for 2 years', 'ipdSharing': 'YES', 'description': 'Consent informs subjects as follows:\n\nIf identifiers are removed from your identifiable information, that information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent. Any future use of the banked data for research outside the scope of this current protocol will be submitted as separate studies to the Institutional Review Board for review and approval, prior to conducting the research', 'accessCriteria': 'Contact with Principal Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lucy D Mastrandrea', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}