Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-02-02 @ 5:11 AM
Study NCT ID:
NCT02818192
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], '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': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma, random urine and buffy coat for DNA extraction will be collected at the baseline visit on all recruited patients that consent to biobanking such that future ancillary studies can be performed. Samples will be processed and frozen at -80 °C, and will be stored for up to 25 years with participant consent. Tests that may be run on stored samples include metabolomics, peptidomics, proteomics, and podocyte microparticle analyses should additional funding be obtained. Samples will be collected at each site and frozen. Periodically samples will be sent to the Canadian Biosample Repository at the University of Alberta for long term storage.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent Albuminuria', 'timeFrame': '2 years', 'description': 'Persistent albuminuria\n\nDefinition:\n\n1. Albumin:creatine (ACR) \\> 3.0mg/mmol in at least two urine samples within 6 months at least 1 month apart.\n2. ACR \\> 3.0mg/mmol with a timed overnight urine or first am urine collection.'}, {'measure': 'Change in albumin excretion over time.', 'timeFrame': '2 years', 'description': 'Change in albumin excretion over 2 years. The change in albumin:creatinine ratio, treated as a continuous outcome measure was selected as a valid evaluation of progression of renal injury over time.'}], 'secondaryOutcomes': [{'measure': 'Change in estimated glomerular filtration rate (eGFR) over time.', 'timeFrame': '2 years', 'description': 'This outcome will be exploratory as significant changes are not expected during a 2-year follow-up period. However, as GFR reflects actual kidney function, this outcome will become increasingly important as chronic kidney disease (CKD) progresses in the cohort over time. GFR will be determined with serum creatinine measurements, utilizing a new eGFR formula for overweight youth, which have been validated utilizing iohexol GFR data from the initial cohort.\n\neGFR will be calculated with the iCARE equation. This equation was previously validated for use in the iCARE cohort.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Proteinuria', 'Stress', 'Nephropathy']}, 'referencesModule': {'references': [{'pmid': '25284698', 'type': 'RESULT', 'citation': 'Dart AB, Wicklow BA, Sellers EA, Dean HJ, Malik S, Walker J, Chateau D, Blydt-Hansen TD, McGavock JM; iCARE investigators. The Improving Renal Complications in Adolescents With Type 2 Diabetes Through the REsearch (iCARE) Cohort Study: rationale and Protocol. Can J Diabetes. 2014 Oct;38(5):349-55. doi: 10.1016/j.jcjd.2014.07.224.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of the project is to elucidate the primary bio-psycho-social (BPS) risk factors for albuminuria in youth with type 2 diabetes (T2D) and the mechanisms by which they cause renal injury. The Study aims include:\n\n1. Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.\n2. Determine individual, family and community level factors that influence biological and psychological risk factors and behaviors (adherence) that could be modified to protect against prevalent and progressive albuminuria.\n3. Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.\n\nStudy Hypotheses include:\n\n1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and psychological and social adversity (stress, mental distress and poverty) are significant predictors of prevalent and progressive albuminuria in youth with T2D.\n2. Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.\n3. Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.', 'detailedDescription': 'The investigators will conduct a case-control study within a two-year, prospective observational cohort study of 500 prevalent cases of T2D diagnosed \\<18 years of age. The investigators will evaluate the primary BPS risk factors associated with prevalent albuminuria using a principal component analysis (PCA) of associations between primary exposure variables at enrollment. After confirming the relevant BPS factors in the PCA analysis, the investigators will utilize a structural equation modeling approach to confirm the developed model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Prevalent youth 10-18 years of age being treated for T2D at 7 pediatric endocrinology clinics across Canada (Stollery Hospital in Edmonton, Alberta Children's Hospital in Calgary, Children's Hospital of Saskatoon, Children's Hospital of Winnipeg, Children's Hospital of Eastern Ontario in Ottawa, SickKids Hospital in Toronto, and the IWK Health Centre in Halifax)", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All youth with T2D that do not meet exclusion criteria are eligible for the study.\n\nCriteria for Diagnosis of T2D:\n\n1. Diagnosis of diabetes will be made according to the Canadian Diabetes Association criteria. There must be 2 abnormal blood glucose tests on different days OR 1 abnormal blood glucose test + symptoms of diabetes:\n\n * Fasting plasma glucose of \\> 7.0 mmol/L or\n * Random glucose \\> 11.1mmol/L or\n * 2 hour glucose \\> 11.1 mmol/L after a standard oral glucose tolerance test (75g) or\n * Hemoglobin A1c value ≥ 6.5%\n2. Distinguishing T2D from type 1 diabetes (T1D) will be based on clinical risk factors including:\n\n * Presence of overweight/obesity,\n * Other evidence of insulin resistance (acanthosis nigricans)\n * Family history of type 2 diabetes (1st degree relative)\n * Intrauterine exposure to hyperglycemia,\n * Family heritage from a high-risk ethnic group (Indigenous, Hispanic, South Asian, Asian or African descent)\n * Absence of diabetes associated auto-antibodies\n * HNF-1 alpha heterozygote or homozygote\n\nExclusion Criteria:\n\n1. Diabetes secondary to medication use or surgery\n2. Antibodies suggestive of type 1 diabetes\n3. Current treatment with oral steroids or immunosuppressive agents as they may interfere with cortisol assessment and inflammatory markers\n4. Ever cancer\n5. Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohns disease)\n6. Patient and or caregiver unable or unwilling to provide voluntary informed assent/consent'}, 'identificationModule': {'nctId': 'NCT02818192', 'acronym': 'iCARE', 'briefTitle': 'Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)', 'orgStudyIdInfo': {'id': 'B2011:024'}}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brandy A Wicklow, MD, MSc', 'role': 'CONTACT', 'email': 'bwicklow@hsc.mb.ca', 'phone': '2047871222'}, {'name': 'Brandy A Wicklow, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Allison Dart, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Research Institute of Manitoba/University of Manitoba", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Brandy A Wicklow, MD, MSc', 'role': 'CONTACT', 'email': 'bwicklow@hsc.mb.ca', 'phone': '2047871222'}, {'name': 'Melissa Del Vecchio, MSc', 'role': 'CONTACT', 'email': 'mdelvecchio@chrim.ca', 'phone': '2047893827'}], 'overallOfficials': [{'name': 'Brandy A Wicklow, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Manitoba, Children's Hospital Research Institute of Manitoba"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This is a multi-site trial where the use and compilation of individual level data is being discussed amongst the various ethics boards across Canada.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Pediatrics and Child Health', 'investigatorFullName': 'Dr. Brandy Wicklow', 'investigatorAffiliation': 'University of Manitoba'}}}}