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NCT Number: NCT02583061

Toronto Gestational Glucose Tolerance Cohort

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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Key information

Conditions

Type 2 Diabetes, Gestational Diabetes, Pre-diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

20 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location status: Recruiting

Location contact

Ravi Retnakaran, MD

CONTACT

[email protected]

416-586-4800 ext. 3941

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women

Exclusion criteria

  • Pre-existing diabetes before the index pregnancy

Treatment and study plan

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

Other

Primary outcomes

  1. Glucose tolerance status

    Time frame: 10 years after pregnancy

    Glucose tolerance is assessed on oral glucose tolerance test

Study contacts

Contact information is provided by the study sponsor or research team.

Ravi Retnakaran, MD

CONTACT

[email protected]

416-586-4800 ext. 3941

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2003
Primary completion
2029
Study completion
2029
First posted
Oct 21, 2015
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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