Actively Recruiting
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
478 weeks
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
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.
CONDITIONS
Official Title
Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth diagnosed with type 2 diabetes before age 18 who do not meet exclusion criteria are eligible
- Diagnosis of diabetes confirmed by Canadian Diabetes Association criteria with 2 abnormal blood glucose tests on different days or 1 abnormal test plus diabetes symptoms
- Blood glucose criteria include fasting plasma glucose > 7.0 mmol/L, random glucose > 11.1 mmol/L, 2-hour glucose > 11.1 mmol/L after oral glucose tolerance test, or HbA1c ≥ 6.5%
- Clinical factors distinguishing type 2 from type 1 diabetes such as overweight/obesity, insulin resistance signs, family history, intrauterine hyperglycemia exposure, high-risk ethnic background, absence of diabetes auto-antibodies, or HNF-1 alpha genotype
You will not qualify if you...
- Diabetes caused by medication use or surgery
- Presence of antibodies indicating type 1 diabetes
- Current use of oral steroids or immunosuppressive agents
- Any history of cancer
- Chronic inflammatory illnesses like juvenile rheumatoid arthritis or Crohn's disease
- Inability or unwillingness of patient or caregiver to provide informed assent or consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Actively Recruiting
Research Team
B
Brandy A Wicklow, MD, MSc
CONTACT
M
Melissa Del Vecchio, MSc
CONTACT
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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