Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-03-12 @ 2:43 AM
Study NCT ID:
NCT01794650
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2013-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guidelines for Post-exercise Dietary Intake in T1DM
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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-14', 'studyFirstSubmitDate': '2013-02-15', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hour blood glucose area under the curve', 'timeFrame': '24 hours', 'description': '24 hour, post-exercise, glucose area under the curve.'}], 'secondaryOutcomes': [{'measure': 'Ketogenesis', 'timeFrame': '60 minutes before and 24 hours post-exercise', 'description': 'Blood beta-hydroxybutyrate concentrations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['T1DM, Exercise, Hypoglycaemia'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesise that manipulating the glycaemic index of the meal after exercise and before sleep will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-50 years old (male or female).\n* Free from any diabetes related complications (apart from mild background diabetic retinopathy).\n* HbA1c \\<8.5%.\n* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.\n* Demonstrate normal cardiac function in response to exercise.\n\nExclusion Criteria:\n\n* Aged younger than 18, or older than 50 years.\n* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).\n* HbA1c \\>8.5%.\n* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.\n* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.'}, 'identificationModule': {'nctId': 'NCT01794650', 'briefTitle': 'Guidelines for Post-exercise Dietary Intake in T1DM', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Metabolic and Glycaemic Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'West-Walker2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Meal composition', 'description': 'Changing the glycaemic index of the meals consumed after exercise and before sleep. (High GI - High GI, Low GI - Low GI, High GI - Low GI, Low GI - High GI).', 'interventionNames': ['Dietary Supplement: Meal composition']}], 'interventions': [{'name': 'Meal composition', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Meal composition']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE10 9PY', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Clinical Research Facility, Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Daniel J West, PhD, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}