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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT05784220
Eligibility Criteria:
Inclusion Criteria:
* Score of 33 or higher using the Canadian Diabetes Risk Assessment (CANRISK) Questionnaire (aged 18 to 74) or;
* Age ≥ 45 and BMI ≥ 30 or;
* Or diagnosed with prediabetes age 18 years or older with an A1c of 6.0-6.4% and/or fasting glucose 6.1-6.9 mmol/L and;
* Access to phone and internet (options include: home, work, friend's home, relative's home, public library, etc.);
Exclusion Criteria:
* Diagnosis of diabetes
* Any glucose lowering medication
* Any prescribed weight loss medication
* Receiving oral/systemic glucocorticoid (steroid) therapy (not including inhalers or nasal sprays) within the past 3 months, or planning to initiate oral/systemic glucocorticoid (steroid) in the next 3 months
* History of acute or chronic pancreatitis
* History of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years
* History of hemoglobinopathy, which may affect HbA1c measurement
* Currently enrolled in a clinical trial involving an investigational drug (need to be free of study medication for 30 days after final visit)
* Pregnancy or becoming pregnant during the study (the participant would be excluded due to weight gain and increased of waist circumference as they contradict the outcomes of the study)
* Dementia/severe cognitive impairment (the study does not have the proper support staff to support participants with specific needs)
* Inability to read English or French, or with personal or family support to interpret material
* Outside the catchment area for lab services (blood and anthropometric collection)
* Weight at baseline greater than upper limit of the scale used
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05784220
Study Brief:
Protocol Section:
NCT05784220