Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT02818192
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT02818192
Study Brief:
Protocol Section:
NCT02818192