Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study) (iCARE)
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|ClinicalTrials.gov Identifier: NCT02818192|
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : April 19, 2022
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:
- Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D.
- 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.
- Determine if systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Study Hypotheses include:
- 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.
- Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria.
- Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
|Condition or disease|
|Type 2 Diabetes Proteinuria Stress Nephropathy|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
- Persistent Albuminuria [ Time Frame: 2 years ]
- Albumin:creatine (ACR) > 2.0mg/mmol in at least two urine samples within 6 months at least 1 month apart.
- ACR > 2.0mg/mmol with a timed overnight urine or first am urine collection.
- Change in albumin excretion over time. [ Time Frame: 2 years ]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.
- Change in estimated glomerular filtration rate (eGFR) over time. [ Time Frame: 2 years ]
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 pediatric Schwartz formula and iCARE equation. This equation was previously validated for use in the iCARE cohort.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818192
|Contact: Brandy A Wicklow, MD, MScemail@example.com|
|Contact: Melissa Del Vecchio, MScfirstname.lastname@example.org|
|Children's Hospital Research Institute of Manitoba/University of Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada, R3E 3P4|
|Contact: Brandy A Wicklow, MD, MSc 2047871222 email@example.com|
|Principal Investigator: Brandy A Wicklow, MD, MSc|
|Principal Investigator: Allison Dart, MD, MSc|
|Principal Investigator:||Brandy A Wicklow, MD, MSc||University of Manitoba, Children's Hospital Research Institute of Manitoba|