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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT05299502
Eligibility Criteria:
Inclusion Criteria:
* ≤ 14 gestational weeks;
* Singleton pregnancy;
* At risk of GDM According to Diabetes Canada (being 35 years of age or older or from a high-risk group (African, Arab, Asian, Hispanic, Indigenous, or South Asian) or having a BMI ≥ 30 kg/m2, prediabetes, GDM in a previous pregnancy, given birth to a baby that weighed more than 4 kg, a parent, brother or sister with type 2 diabetes, polycystic ovary syndrome or acanthosis nigricans (darkened patches of skin).
Exclusion Criteria:
* Having a diabetes diagnosis in the 1st trimester;
* Pre-existing diabetes mellitus;
* Diseases requiring active nutritional treatment or influencing glucose metabolism (including previous bariatric surgery);
* Taking part in a nutritional intervention program;
* Corticosteroid use;
* Previous or current diagnosis of an eating disorder;
* Inability to give informed consent;
* Inability to communicate in French.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05299502
Study Brief:
Protocol Section:
NCT05299502