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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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:
Study Hypotheses include:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Persistent Albuminuria | Persistent albuminuria Definition:
| 2 years |
| Change in albumin excretion over time. | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) over time. | 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. eGFR will be calculated with the iCARE equation. This equation was previously validated for use in the iCARE cohort. |
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Inclusion Criteria:
Criteria for Diagnosis of T2D:
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:
Distinguishing T2D from type 1 diabetes (T1D) will be based on clinical risk factors including:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandy A Wicklow, MD, MSc | Contact | 2047871222 | bwicklow@hsc.mb.ca | |
| Melissa Del Vecchio, MSc | Contact | 2047893827 | mdelvecchio@chrim.ca |
| Name | Affiliation | Role |
|---|---|---|
| Brandy A Wicklow, MD, MSc | University of Manitoba, Children's Hospital Research Institute of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Research Institute of Manitoba/University of Manitoba | Recruiting | Winnipeg | Manitoba | R3E 3P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25284698 | Result | 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. |
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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.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011507 | Proteinuria |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
| 2 years |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |