Toronto Gestational Glucose Tolerance Cohort
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Glucose tolerance status
Study Overview
Brief Summary
In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.
Detailed Description
In this prospective observational cohort study, women reflecting the full spectrum of glucose tolerance in pregnancy (from gestational diabetes mellitus (GDM) to lesser degrees of gestational glucose intolerance to those with completely normal glucose tolerance) are being recruited in late 2nd trimester. This cohort of women thus carries a broad range of risk for the future development of type 2 diabetes (T2DM) and cardiovascular disease. At regular intervals in the years after the index pregnancy, this cohort of women is undergoing serial cardiometabolic characterization, including assessment of glucose tolerance, beta-cell function and insulin sensitivity. The longitudinal changes over time in this cohort should provide insight into the early pathophysiology and natural history of T2DM and cardiovascular disease.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant women
Exclusion Criteria
- •Pre-existing diabetes before the index pregnancy
Outcomes
Primary Outcomes
Glucose tolerance status
Time Frame: 10 years after pregnancy
Glucose tolerance is assessed on oral glucose tolerance test
Secondary Outcomes
No secondary outcomes reported