Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)

Recruiting now

Conditions studied: Type 2 Diabetes, Proteinuria, Stress, Nephropathy

In brief

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.

Key facts

Study ID

NCT02818192

Run by

University of Manitoba

People needed

500

Starts

2017-01-01

Expected to finish

2027-03-01

Last updated by the study team

2026-06-29

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) or
• Hemoglobin A1c value ≥ 6.5%
• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Research Institute of Manitoba/University of Manitoba — Winnipeg, Manitoba, Canada (enrolling)

Full record on ClinicalTrials.gov

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