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
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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:
- 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
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|Ages Eligible for Study:||10 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- All youth with T2D that do not meet exclusion criteria are eligible for the study.
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:
- Fasting plasma glucose of > 7.0 mmol/L or
- Random glucose > 11.1mmol/L or
- 2 hour glucose > 11.1 mmol/L after a standard oral glucose tolerance test (75g).
Distinguishing T2D from type 1 diabetes (T1D) will be based on clinical risk factors including:
- Presence of overweight/obesity,
- Other evidence of insulin resistance (acanthosis nigricans)
- Family history of type 2 diabetes (1st degree relative)
- Intrauterine exposure to hyperglycemia,
- Family heritage from a high-risk ethnic group (Indigenous, Hispanic, South Asian, Asian or African descent)
- Absence of diabetes associated auto-antibodies
- HNF-1 alpha heterozygote or homozygote
- Diabetes secondary to medication use or surgery
- Antibodies suggestive of type 1 diabetes
- Current treatment with oral steroids or immunosuppressive agents as they may interfere with cortisol assessment and inflammatory markers
- Ever cancer
- Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohns disease)
- Patient and or caregiver unable or unwilling to provide voluntary informed assent/consent
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|
|Responsible Party:||Dr. Brandy Wicklow, Assistant Professor, Pediatrics and Child Health, University of Manitoba|
|Other Study ID Numbers:||
|First Posted:||June 29, 2016 Key Record Dates|
|Last Update Posted:||April 19, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan 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.|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases