Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT03400618
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carbohydrate Content in the Diet in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The difference in Mean Amplitude of Glycemic Excursions (MAGE)', 'timeFrame': 'Week 3-4, week 11-12', 'description': 'Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12'}, {'measure': 'HbA1c', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in HbA1c between week 4 and week 12'}, {'measure': 'Apolipoproteins', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in apolipoproteins between week 4 and week 12'}, {'measure': 'The difference in the proportion of time with low glucose levels', 'timeFrame': 'Week 3-4, week 11-12', 'description': 'Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12'}, {'measure': 'Ketones', 'timeFrame': 'Week 1-4, week 9-12', 'description': 'The difference in ketone levels between week 1-4 and week 9-12'}, {'measure': 'Ketoacidosis', 'timeFrame': 'Week 1-4, week 9-12', 'description': 'Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12'}], 'primaryOutcomes': [{'measure': 'The difference in mean glucose level', 'timeFrame': 'Week 3-4, week 11-12', 'description': 'Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12'}], 'secondaryOutcomes': [{'measure': 'The difference in standard deviation of glucose levels', 'timeFrame': 'Week 3-4, week 11-12', 'description': 'Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12'}, {'measure': 'The difference in the proportion of time with high glucose levels', 'timeFrame': 'Week 3-4, week 11-12', 'description': 'Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12'}, {'measure': 'The difference in the proportion of time with euglycaemic levels', 'timeFrame': 'Week 3-4, week 11-12', 'description': 'Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12'}, {'measure': 'Weight', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in weight between week 4 and week 12'}, {'measure': 'Total cholesterol', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in total cholesterol between week 4 and week 12'}, {'measure': 'LDL cholesterol', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in LDL cholesterol between week 4 and week 12'}, {'measure': 'HDL cholesterol', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in HDL cholesterol between week 4 and week 12'}, {'measure': 'Triglycerides', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in triglycerides between week 4 and week 12'}, {'measure': 'Total insulin dose', 'timeFrame': 'Week 1-4, week 9-12', 'description': 'The difference in total insulin dose between week 1-4 and week 9-12'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire (DTSQc) score', 'timeFrame': 'Week 12', 'description': 'The difference in DTSQc score at week 12'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire (DTSQs) score', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in DTSQs scores between week 4 and week 12'}, {'measure': 'Hypoglycemia confidence score', 'timeFrame': 'Week 4, week 12', 'description': 'The difference in hypoglycaemia confidence scores between week 4 and week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbohydrates', 'Diet', 'Diabetes Mellitus, Type 1'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '36992911', 'type': 'DERIVED', 'citation': 'Sterner Isaksson S, Olafsdottir AF, Lind M. Design of a randomized cross-over study evaluating effects of carbohydrate intake on glycemic control in persons with type 1 diabetes. Front Nutr. 2023 Mar 13;10:1114317. doi: 10.3389/fnut.2023.1114317. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).\n\nThe trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* Adults 18 years or older\n* Written Informed Consent\n* HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)\n\nExclusion Criteria:\n\n* Pregnancy or planned pregnancy for the study duration\n* Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion\n* Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.\n* Diabetes duration \\< 1 year\n* Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period\n* Other investigator-determined criteria unsuitable for patient participation'}, 'identificationModule': {'nctId': 'NCT03400618', 'briefTitle': 'Carbohydrate Content in the Diet in Type 1 Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'Carbohydrate study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate carbohydrate diet', 'description': 'A healthy diet containing 30 E % carbohydrates', 'interventionNames': ['Other: Moderate carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Higher carbohydrate diet', 'description': 'A healthy diet containing 50 E % carbohydrates', 'interventionNames': ['Other: Higher carbohydrate diet']}], 'interventions': [{'name': 'Moderate carbohydrate diet', 'type': 'OTHER', 'description': '30 E % carbohydrates included in the diet', 'armGroupLabels': ['Moderate carbohydrate diet']}, {'name': 'Higher carbohydrate diet', 'type': 'OTHER', 'description': '50 E % carbohydrates included in the diet', 'armGroupLabels': ['Higher carbohydrate diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45180', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'NU Hospital Organization', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}], 'overallOfficials': [{'name': 'Marcus Lind, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NU Hospital Organization/University of Gothenburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}