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Recruiting NCT02583061

Toronto Gestational Glucose Tolerance Cohort

Observational Type 2 Diabetes, Gestational Diabetes, Pre-diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: There is no intervention. An exposure of interest is glucose tolerance status in pregnancy.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Gestational Diabetes, Pre-diabetes. Basic parameters: 20 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other There is no intervention. An exposure of interest is glucose tolerance status in pregnancy

Primary outcome measures

  • Glucose tolerance status [Time frame: 10 years after pregnancy]

Eligibility criteria

Inclusion criteria

  • Pregnant women

Exclusion criteria

  • Pre-existing diabetes before the index pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Mount Sinai Hospital — Toronto

Identifiers

NCT: NCT02583061 · 01-0318-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗