Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02054832
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C538655', 'term': 'Hepatorenal form of glycogen storage disease'}, {'id': 'C562594', 'term': 'Glycogen Storage Disease IB'}, {'id': 'D006010', 'term': 'Glycogen Storage Disease Type III'}], 'ancestors': [{'id': 'D006008', 'term': 'Glycogen Storage Disease'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2014-01-31', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To describe the variability in glucose fluctuations with Glycosade using a CGM sensor.', 'timeFrame': '1 week', 'description': 'Glucose will be monitored with the aid of the CGM sensor for 5 to 7 days while starting Glycosade.'}, {'measure': 'To establish if metabolic control is maintained using Glycosade.', 'timeFrame': '24 hours', 'description': 'Metabolic control in hospital after starting Glycosade will be defined as the absence of deterioration of biochemical data at the end of fast compared to during the fast.'}, {'measure': 'To evaluate the safety profile of Glycosade, based on the frequency of side effects, e.g. gastrointestinal side effects while receiving Glycosade.', 'timeFrame': '1 month', 'description': 'Subjects will be constantly monitored for adverse events throughout the study. They will be asked to keep a diary to document side effects while receiving Glycosade. They will also be asked at each visit whether they experienced any known or unknown side effects.'}, {'measure': 'To assess the acceptability/palatability of Glycosade.', 'timeFrame': '1 month', 'description': 'Patient report (or parent report on behalf of child) of palatability at 4 weeks after starting Glycosade compared to their previous regimen.'}], 'primaryOutcomes': [{'measure': 'The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by GSD adults and children and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycaemia.', 'timeFrame': '2 weeks', 'description': 'Parents will be asked to complete a quality of sleep questionnaire (as it pertains to both child and parent) relating to the past month on their current dietary regimen (standard UCCS). Parents will also complete a sleep diary (for both child and parent) and both child and parent will wear an actigraph that will record movements during sleep over a 1 week period prior to Glycosade. The actigraphy and the sleep diary will be repeated after 2 weeks (for 2 weeks) while on Glycosade. The quality of sleep questionnaire will be repeated after 1 month on Glycosade. Adult GSD patients will complete their own questionnaires.'}], 'secondaryOutcomes': [{'measure': 'To evaluate if there is a change in quality of life perceived by GSD adults and children and their parents with Glycosade.', 'timeFrame': '1 month', 'description': 'Parents (as it pertains to their child) and adult patients will be asked to complete quality of life questionnaire prior to Glycosade and 1 month after starting this new diet.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glycogen Storage Disease Type IA', 'Glycogen Storage Disease Type IB', 'Glycogen Storage Disease Type III', 'Glycogen Storage Disease Type 0']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by adults and children with GSD and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if there is a change in quality of life perceived by adults and children and their parents with Glycosade.', 'detailedDescription': 'This is a prospective cohort study. Patients above 2 years old and their parents (for children only) will be enrolled during their usual follow-up. Parents will be asked to complete a quality of sleep questionnaire (as it pertains to both child and parent) relating to the past month on their current dietary regimen (standard UCCS) and a quality of life questionnaire (as it pertains to the child only). Parents will then complete a sleep diary (for both child and parent) and both child and parent will wear an actigraph that will record movements during sleep over a 1 week period. Adult GSD patients will complete their own questionnaires. Following this first assessment, they will be hospitalised over a 24 hour period as part of standard of care to start the modified UCCS, Glycosade, under supervision and with a continuous glucose monitoring (CGM) sensor. Following hospitalization, the family will return home. Glucose will be monitored with the aid of the CGM sensor for 5 to 7 days. The actigraphy and the sleep diary will be repeated after 2 weeks (for 1 week) while on Glycosade. One month after starting the modified UCCS, questionnaires on quality of sleep and quality of life will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Glycogen Storage Disease taking uncooked cornstarch to prevent hypoglycemia followed at the Montreal Children's Hospital and St-Luc Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of ≥ 2 years old with a diagnostic of GSD 0, I, III, VI, IX or XI based on a liver biopsy, mutation in the appropriate gene or clinical evidence of GSD with a positive familial history\n* Medical history of fasting hypoglycemia\n* Currently taking standard UCCS\n* With a stable condition\n* Followed in GSD clinics at the Montreal Children's Hospital and the Hôpital St-Luc\n* With informed consent obtained\n\nExclusion Criteria:\n\n* Continuous overnight feeds"}, 'identificationModule': {'nctId': 'NCT02054832', 'briefTitle': 'Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'A Comparison of Quality of Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard and Modified Uncooked Cornstarch', 'orgStudyIdInfo': {'id': '12-337-PED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glycosade', 'description': 'A prospective cohort design will be used to assess the impact on sleep and continue to monitor safety of Glycosade.', 'interventionNames': ['Dietary Supplement: Glycosade']}], 'interventions': [{'name': 'Glycosade', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Glycosade']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3H1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'John J Mitchell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Montreal Children's Hospital of the MUHC"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Mitchell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division Head, Endocrinology', 'investigatorFullName': 'John Mitchell', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}