Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-05 @ 1:16 AM
Study NCT ID:
NCT03122093
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Daily Gluten Intake', 'timeFrame': '2 Years', 'description': 'This outcome will be measured through interview/assessment data.'}, {'measure': 'Celiac Dietary Adherence', 'timeFrame': '2 Years', 'description': 'This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire.'}, {'measure': 'TTG-IgA Serology', 'timeFrame': '2 Years', 'description': 'This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease.'}], 'secondaryOutcomes': [{'measure': 'Health-related Quality of Life', 'timeFrame': '2 Years', 'description': 'This outcome will be measured through the self-reported Quality of Life (PedsQL) Inventory Generic Core Scale (V.4.0) with Diabetes Module (V.3.0).'}, {'measure': 'Daily Activity Levels', 'timeFrame': '2 Years', 'description': 'This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES).'}, {'measure': 'Self-Perceived Wellness', 'timeFrame': '2 Years', 'description': 'This outcome will be measured through a self-reported Self-Perceived Wellness Scale.'}, {'measure': 'Metabolic Control', 'timeFrame': '2 years', 'description': 'This outcome will be measured through self-reports and lab-provided HbA1c values.'}, {'measure': 'Kidney Function', 'timeFrame': '2 years', 'description': 'This outcome will be measured through lab-provided Albumin/Creatinine Ratios.'}, {'measure': 'Hypoglycemic episodes.', 'timeFrame': '2 years', 'description': 'The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report.'}, {'measure': 'Presence of Type 1 Diabetes Complications', 'timeFrame': '10 years', 'description': 'This outcome will be measured by monitoring the occurence of T1D health outcomes and complications over time through long-term medical record review follow-up. Complications include, but are not limited to: nephropathy, retinopathy, and cardiovascular disease in the study population.'}, {'measure': 'Presence of Celiac Disease Complications', 'timeFrame': '10 years', 'description': 'This outcome will be measured by monitoring the occurence of celiac disease health outcomes and complications over time through long-term medical record review follow-up. Complications include, but are not limited to: osteoporosis and malnutrition in the study population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'dietary treatment', 'celiac disease', 'T1D'], 'conditions': ['Celiac Disease', 'Celiac', 'Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': "To the investigators' knowledge, no single long-term prospective observational study has assessed dietary factors, diabetes clinical variables (metabolic control and associated complications), and self -perceived health and wellness in T1D patients (both pediatric and adult) with CD identified by screening (positive/weakly positive serology). The aim of the current study is to observe the short- and long-term outcomes for Type 1 diabetic patients with new serology positive asymptomatic CD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an established diagnosis of T1D and positive/weakly positive serologic CD after entering the screening portion of the CD-DIET study will be recruited to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females between the ages of 8 and 50 years with positive/weakly positive serologic CD screening or who have completed the CD-DIET trial.\n2. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D equal to or greater than 1 year from time of signing Screening Informed Consent for CD-DIET trial.\n3. Ability of the subject or a legally authorized representative to speak and read English or French.\n4. Participation in the screening portion of the CD-DIET Study.\n\nExclusion Criteria:\n\n1\\. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT03122093', 'acronym': 'CD-LiFE', 'briefTitle': 'Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study (CD-LiFE)', 'orgStudyIdInfo': {'id': '1000053646'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CD-DIET Gluten-Free Diet Group', 'description': 'This former randomized control trial (RCT) group received a gluten-free education and continued support from a dietitian for a 1-year period via the CD-DIET Study (NCT01566110)'}, {'label': 'CD-DIET Gluten-Containing Diet Group', 'description': 'This former RCT group did not receive a gluten-free education and 1-year support from a dietitian via the CD-DIET Study (NCT01566110), but rather a single gluten-free education session upon exiting the study.'}, {'label': 'CD-DIET Ineligibles/Refusals', 'description': 'This group contains T1D/CD individuals who were not eligible or refused to join the CD-DIET RCT (e.g. already self-selected their diet or had no interest in being randomized). These individuals were instead redirected to the clinical route.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5V1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Farid Mahmud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Staff Physician', 'investigatorFullName': 'Farid Mahmud', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}