Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-01 @ 3:10 PM
Study NCT ID:
NCT05078658
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-carbohydrate Diet in Children with Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period', 'timeFrame': 'Month 1 - Month 24'}], 'secondaryOutcomes': [{'measure': 'Changes in mean insulin dose during the LCD period compared to the RCD period', 'timeFrame': 'Month 1 - Month 24'}, {'measure': 'Changes in mean body weight standard deviation score during the LCD period compared to the RCD period', 'timeFrame': 'Month 1 - Month 24'}, {'measure': 'Changes in the lipid spectrum during the LCD period compared to the RCD period', 'timeFrame': 'Month 1 - Month 24'}, {'measure': 'Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period', 'timeFrame': 'Month 1 - Month 24'}, {'measure': 'Changes in lymphocyte subgroup cell counts (flow cytometry) during the LCD period', 'timeFrame': 'Month 1 - Month 36'}, {'measure': 'Differences in faecal microbiome between the LCD and RCD periods', 'timeFrame': 'Month 1 - Month 36'}, {'measure': 'Differences in faecal metabolome between the LCD and RCD periods', 'timeFrame': 'Month 1 - Month 36'}, {'measure': 'Differences in serum metabolome between the LCD and RCD periods', 'timeFrame': 'Month 1 - Month 36'}, {'measure': 'Differences in urine metabolome between the LCD and RCD periods', 'timeFrame': 'Month 1 - Month 36'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1diabetes']}, 'descriptionModule': {'briefSummary': 'The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD).\n\nSecondary objectives are:\n\nChanges in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria\n* T1D duration for at least 1 year prior to the intervention\n* continuous glucose monitor (CGM) worn \\> 70% time in the month prior to the intervention\n\nExclusion Criteria:\n\n* last HbA1c \\< 40 or \\> 70 mmol/mol\n* subject has celiac disease\n* daily average carbohydrate intake \\< 130 g/day from 14 days food record prior to the intervention\n* any concomitant disease possibly affecting glucose control\n* any chronic medication possibly affecting glucose control'}, 'identificationModule': {'nctId': 'NCT05078658', 'acronym': 'Lowca', 'briefTitle': 'Low-carbohydrate Diet in Children with Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Motol'}, 'officialTitle': 'Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity', 'orgStudyIdInfo': {'id': 'NU21-01-00085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-carbohydrate diet', 'description': 'The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.', 'interventionNames': ['Other: Low-carbohydrate diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recommended carbohydrate diet', 'description': 'The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with 50% (+/- 5%) of the recommended energy from carbohydrates.', 'interventionNames': ['Other: Recommended-carbohydrate diet']}], 'interventions': [{'name': 'Low-carbohydrate diet', 'type': 'OTHER', 'description': 'The diet will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.', 'armGroupLabels': ['Low-carbohydrate diet']}, {'name': 'Recommended-carbohydrate diet', 'type': 'OTHER', 'description': 'The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with the amount of carbohydrates equal to 45% (+/- 5%) of the recommended energy a day.', 'armGroupLabels': ['Recommended carbohydrate diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CZ-15600', 'city': 'Prague', 'state': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Motol', 'class': 'OTHER'}, 'collaborators': [{'name': 'Czech Academy of Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Zdeněk Šumník', 'investigatorAffiliation': 'University Hospital, Motol'}}}}