The Improving Renal Complications in Adolescents With Type 2 Diabetes Through the REsearch (iCARE) Cohort Study: rationale and Protocol.
Allison B Dart, Brandy A Wicklow, Elizabeth A Sellers...
https://pubmed.ncbi.nlm.nih.gov/25284698Actively Recruiting
Age: 10Years - 18Years
All Genders
ID02818192
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Led by University of Manitoba · Updated on 2024-06-07
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying youth aged 10 to 18 years with type 2 diabetes (T2D) to understand the main biological, psychological, and social risk factors that contribute to albuminuria, a sign of kidney damage. The study aims to identify how factors like poor blood sugar control, blood pressure, stress, mental distress, poverty, family, and community support affect kidney health in these young people. It also explores whether inflammation in the body and kidneys links these risk factors to kidney injury. This research involves a two-year, observational study following 500 young people diagnosed with T2D before age 18. The study uses advanced data analysis methods to find patterns in risk factors and confirm how they relate to albuminuria. There are no treatment interventions; instead, participants are observed to gather information about their health and risk factors over time. Participants will be evaluated at enrollment and followed for two years to measure persistent albuminuria and changes in albumin excretion, alongside kidney function measured by estimated glomerular filtration rate (eGFR). Data collection includes assessments of biological, psychological, and social factors. The study tracks how these relate to kidney health and inflammation, helping researchers better understand complications in youth with T2D.
CONDITIONS
Brief Title
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Who Can Participate
Age: 10Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Youth aged 10 to 18 years diagnosed with type 2 diabetes before age 18
- Diagnosis made by Canadian Diabetes Association criteria with abnormal blood glucose tests or elevated hemoglobin A1c
- Diagnosis supported by clinical risk factors distinguishing type 2 from type 1 diabetes, such as overweight/obesity, insulin resistance signs, family history, ethnic background, and absence of diabetes auto-antibodies
- Willingness and ability to provide voluntary informed assent/consent
You will not qualify if you...
- Diabetes caused by medication use or surgery
- Presence of antibodies indicating type 1 diabetes
- Current treatment with oral steroids or immunosuppressive agents
- History of cancer
- Chronic illnesses linked to systemic inflammation (e.g., juvenile rheumatoid arthritis, Crohn's disease)
- Inability or unwillingness to provide voluntary informed assent/consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Long-term Monitoring
Duration - 2 years
Participants are observed over time to evaluate kidney function and albumin levels in relation to type 2 diabetes.
Trial Site Locations
Total: 1 location
1
Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Actively Recruiting
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Research Team
B
Brandy A Wicklow, MD, MSc
M
Melissa Del Vecchio, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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