NCT01340924

Brief Summary

The overall objective of this research project is to study the impact of preventive practices on the T2D-related risk profile among women with and without prior GDM and their children exposed and unexposed to GDM.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

7 years

First QC Date

March 15, 2011

Last Update Submit

April 7, 2022

Conditions

Keywords

Gestational diabetesType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance assessed using a 75g-Oral Glucose Tolerance Test (OGTT) in mothers

    1 year

Secondary Outcomes (7)

  • Glycaemic and lipidic profile assessed using a fasting blood sample in children

    1 year

  • overweight/obesity

    1 year

  • abdominal obesity

    1 year

  • metabolic syndrome

    1 year

  • Breastfeeding

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In order to avoid selection biases, we plan to recruit 450 women with a history of GDM through administrative data from the Régie de l'assurance maladie du Québec (RAMQ) and children of those mothers. We plan to recruit 125 women without history of GDM through mail sent to students and employees of local university and children of those mothers.

You may qualify if:

  • Women aged ≥18 years with or without a diagnosis of GDM in the past 3-12 years and their children.

You may not qualify if:

  • Pregnant women, women with type 1 diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University, Institute of Nutraceuticals and Functional Foods

Québec, G1V 0A6, Canada

Location

Related Publications (1)

  • Kearney M, Perron J, Marc I, Weisnagel SJ, Tchernof A, Robitaille J. Association of prenatal exposure to gestational diabetes with offspring body composition and regional body fat distribution. Clin Obes. 2018 Apr;8(2):81-87. doi: 10.1111/cob.12237. Epub 2017 Dec 13.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood; serum; white cell.

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julie Robitaille, R.D., Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2011

First Posted

April 25, 2011

Study Start

September 1, 2009

Primary Completion

September 1, 2016

Study Completion

December 1, 2023

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations