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Toronto Gestational Glucose Tolerance Cohort

NCT ID: NCT02583061

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2029-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes, Gestational Diabetes, Pre-diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women

Exclusion Criteria

* Pre-existing diabetes before the index pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ravi Retnakaran, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ravi Retnakaran, MD

Role: CONTACT

[email protected]
416-586-4800 ext. 3941

Facility Contacts

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Ravi Retnakaran, MD

Role: primary

[email protected]
416-586-4800 ext. 3941

Other Identifiers

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01-0318-E

Identifier Type: -

Identifier Source: org_study_id

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