Understanding kidney issues in adolescents with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: bwicklow@hsc.mb.ca
• Phone: 2047871222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.