Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-18
SponsorUniversity of Manitoba
About this trial
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:
1. Characterize the primary BPS risk factors associated with prevalent and progressive albuminuria in youth with T2D. 2. 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. 3. 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:
1. 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. 2. Community and family support will be negatively associated with stress, and a lower risk of both prevalent and progressive albuminuria. 3. Systemic and renal inflammation is the common pathway through which BPS risk factors lead to albuminuria in youth with T2D.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All youth with T2D that do not meet
Disqualifiers
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) or
Hemoglobin A1c value ≥ 6.5%
Trial population
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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Persistent Albuminuria
Persistent albuminuria Definition: 1. Albumin:creatine (ACR) \> 3.0mg/mmol in at least two urine samples within 6 months at least 1 month apart. 2. ACR \> 3.0mg/mmol with a timed overnight urine or first am urine collection.
Time frame
2 years2
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.
Time frame
2 yearsSecondary outcomes
1
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.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manitoba
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov