Toronto Gestational Glucose Tolerance Cohort

October 19, 2023 updated by: Mount Sinai Hospital, Canada
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of pregnant women across the full spectrum of gestational glucose tolerance

Description

Inclusion Criteria:

  • Pregnant women

Exclusion Criteria:

  • Pre-existing diabetes before the index pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance status
Time Frame: 10 years after pregnancy
Glucose tolerance is assessed on oral glucose tolerance test
10 years after pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Ravi Retnakaran, MD, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimated)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-0318-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on There is no intervention. An exposure of interest is glucose tolerance status in pregnancy

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