Toronto Gestational Glucose Tolerance Cohort

Type 2 Diabetes, Gestational Diabetes, Pre-diabetes Clinical Trial

Official title:

Toronto Gestational Glucose Tolerance Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583061
• Other study ID #: 01-0318-E
• Status: Recruiting
• Start date: September 2003
• Est. completion date: January 2027

Study information

• Verified date: October 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Ravi Retnakaran, MD
• Phone: 416-586-4800
• Email: ravi.retnakaran[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Pregnant women

Exclusion Criteria:

• Pre-existing diabetes before the index pregnancy

Related Conditions & MeSH terms

• Diabetes, Gestational
• Prediabetic State
• Type 2 Diabetes, Gestational Diabetes, Pre-diabetes

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance status	Glucose tolerance is assessed on oral glucose tolerance test	10 years after pregnancy