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

Launched by UNIVERSITY OF MANITOBA · Jun 28, 2016

Keywords

ClinConnect Summary

The National iCARE Study is a clinical trial aimed at understanding the factors that contribute to kidney problems, specifically albuminuria, in adolescents with type 2 diabetes (T2D). Albuminuria is a condition where protein leaks into the urine, which can be a sign of kidney damage. The researchers want to explore biological, psychological, and social factors that may lead to this issue, including things like stress and family support. They hope to find out how these factors affect kidney health and if inflammation in the body plays a role in this process.

To participate in the study, young people aged 10 to 18 with type 2 diabetes can join if they meet certain criteria, such as having a confirmed diagnosis of T2D. Participants will share information about their health, family, and community situations, which will help the researchers understand how these elements interact with kidney health. The study is currently recruiting participants, and those who join will have the opportunity to contribute to important research that may improve health outcomes for other adolescents with diabetes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All youth with T2D that do not meet exclusion criteria are eligible for the study.
• Criteria for Diagnosis of T2D:
• 1. 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%
• 2. 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
• Exclusion Criteria:
• • 1. Diabetes secondary to medication use or surgery
• • 2. Antibodies suggestive of type 1 diabetes
• • 3. Current treatment with oral steroids or immunosuppressive agents as they may interfere with cortisol assessment and inflammatory markers
• • 4. Ever cancer
• • 5. Other chronic illness associated with systemic inflammation (ex. Juvenile rheumatoid arthritis, Crohns disease)
• • 6. Patient and or caregiver unable or unwilling to provide voluntary informed assent/consent