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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01589757
Eligibility Criteria:
MAIN STUDY
Inclusion Criteria:
Women:
1. ≥ 18 years of age
2. diagnosed with gestational diabetes mellitus (GDM) or impaired glucose tolerance of pregnancy (IGTP) according to Canadian Diabetes Association (CDA) criteria
3. being followed within DIP (one of 4 sites)
4. willing and able to give informed consent
5. willing and able to comply with the study protocol
Exclusion Criteria:
Women:
1. with acute or chronic illness other than GDM or IGTP or use of drug (other than insulin) which may affect carbohydrate metabolism, gastrointestinal function or carbohydrate digestion (i.e. crohn's disease, HIV/AIDS, liver disease, kidney disease etc.).
2. known to have type 1 or type 2 DM prior to pregnancy
3. known multi-fetal pregnancy at enrolment
4. ≥ 33 weeks' gestation
5. prescribed oral anti-hyperglycaemic medication
6. insurmountable language barriers
SUB-STUDY control group (women without GDM) Same as for Main study except absence of GDM
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01589757
Study Brief:
Protocol Section:
NCT01589757