NCT02818192 Improving Renal Complications in Adolescents With Type 2 Diabetes Through REsearch Cohort Study (National iCARE Study)
| NCT ID | NCT02818192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manitoba |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2017-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2017-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Brandy A Wicklow, MD, MSc
PRINCIPAL INVESTIGATOR
University of Manitoba, Children's Hospital Research Institute of Manitoba
Frequently Asked Questions
Who can join the NCT02818192 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02818192 currently recruiting?
Yes, NCT02818192 is actively recruiting participants. Contact the research team at bwicklow@hsc.mb.ca for enrollment information.
Where is the NCT02818192 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT02818192 clinical trial?
NCT02818192 is sponsored by University of Manitoba. The principal investigator is Brandy A Wicklow, MD, MSc at University of Manitoba, Children's Hospital Research Institute of Manitoba. The trial plans to enroll 500 participants.
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