Status:
ACTIVE_NOT_RECRUITING
Healthy Eating in Women at Risk of Gestational Diabetes
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Laval University
Conditions:
Gestational Diabetes
Pregnancy Complications
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Healthy eating during pregnancy has favorable effects on markers related to diabetes (glucose tolerance) and is associated with lower gestational diabetes mellitus (GDM) risk. The cornerstone of GDM t...
Detailed Description
Individuals will participate in three on-site research visits during which a 2-hour oral glucose tolerance test will be performed. At each of these trimesters and 3 months after the delivery, particip...
Eligibility Criteria
Inclusion
- ≤ 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
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05299502
Start Date
June 30 2022
End Date
February 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
CHU de Québec-Université Laval
Québec, Quebec, Canada, G1V 4G2