Understanding kidney issues in adolescents with type 2 diabetes

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

This study is trying to find out what biological, psychological, and social factors might be causing kidney problems in teenagers with type 2 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 10 Years to 18 Years
• Sex: All
• Sponsor: University of Manitoba (Academic / other)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT02818192 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify the bio-psycho-social risk factors contributing to kidney damage, specifically albuminuria, in adolescents diagnosed with type 2 diabetes. It will involve a cohort of 500 youth under 18 years of age, analyzing various biological, psychological, and social factors that may influence kidney health. The study will utilize principal component analysis to determine key risk factors and structural equation modeling to confirm the relationships between these factors and albuminuria. The ultimate goal is to uncover mechanisms that lead to renal injury in this population.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents under 18 years old who have been diagnosed with type 2 diabetes.

Not a fit: Patients with type 1 diabetes or those who do not meet the criteria for type 2 diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for preventing kidney complications in adolescents with type 2 diabetes.

How similar studies have performed: Other studies have explored similar bio-psycho-social factors in diabetes management, but this specific approach focusing on adolescents with type 2 diabetes and renal complications is relatively novel.

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

Where this trial is running

Winnipeg, Manitoba

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

Study contacts

• Principal investigator: Brandy A Wicklow, MD, MSc — University of Manitoba, Children's Hospital Research Institute of Manitoba
• Study coordinator: Brandy A Wicklow, MD, MSc

Conditions Type 2 Diabetes; Proteinuria; Stress; Nephropathy