The Next Generation Longitudinal Birth Cohort Diabetes Study (NextGen)

June 30, 2026 updated by: Dr. Brandy Wicklow, University of Manitoba

Genetic and Environmental Influences on Development of Type 2 Diabetes in Childhood: The Next Generation Longitudinal Birth Cohort.

The overall aim of this project is to understand the independent roles of maternal factors, intrauterine exposures, genetic factors, and postnatal environment on the development of obesity and youth-onset type 2 diabetes (T2D) in childhood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Our primary objective for the study is to clinically and metabolically phenotype parents and their offspring to identify risk factors for obesity, T2D, and cardiometabolic risk in childhood and adolescence in a prospective birth cohort by reporting:

  1. Maternal and/or paternal factors including anthropometrics, metabolic parameters, HNF1a genotype, lifestyle (diet and physical activity), and socioeconomic environment.
  2. Infant factors including anthropometrics, early infant nutrition, and metabolism.

Secondary Objectives:

  1. To evaluate if children born to mothers with T2D prior o pregnancy are at increased risk of obesity and T2D.
  2. To determine the modifiable risk factors which contribute to the increased risk of obesity and T2D.
  3. To evaluate the differential risk between mothers and fathers with T2D in terms of somatic and genetic contributions to risk compared to intrauterine environmental contributions to risk.
  4. To plan a large-scale, randomized, controlled community-based breastfeeding intervention with intensive breastfeeding counseling and support for the prevention of T2D development in offspring of mothers or fathers with youth onset T2D.
  5. To explore potential new research questions and feasibility studies for epigenetic studies using cord blood under the umbrella of the new research theme on T2D at the Children's Hospital Research Institute of Manitoba.

Study Type

Observational

Enrollment (Estimated)

600

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 Contact Backup

  • Name: Elizabeth AC Sellers, MD, MSc
  • Phone Number: 204-787-3011
  • Email: esellers@hsc.mb.ca

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Recruiting
        • Children's Hospital Research Institute of Manitoba/University of Manitoba
        • Contact:

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children between the age of 0 and 18 or until a diagnosis of type 2 diabetes.

Diagnosis of diabetes will be made according to the Canadian Diabetes Association criteria. There must be 2 abnormal blood glucose tests on different days OR 1 abnormal blood glucose test + symptoms of diabetes:

Fasting plasma glucose of > 7.0 mmol/L or Random glucose > 11.1mmol/L or 2-hour glucose > 11.1 mmol/L after a standard oral glucose tolerance test (75g).

Description

Inclusion Criteria:

  • Pregnant women with type 2 diabetes, gestational diabetes, or no diabetes.
  • From self-identified Indigenous heritage (e.g., Cree, Oji-Cree, Métis, Anishinaabe, etc.).
  • Are delivering and residing in Manitoba.
  • Mother/Father and children must be biological family members.

Exclusion Criteria:

  • Mothers or children with type 1 diabetes.
  • Residing outside of Manitoba.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Next Generation Cohort
We will follow the children from mothers who either have T2D, GDM, or are controls.
Other: Observational screening study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obesity
Time Frame: 18 years
Development of obesity defined by the International task force on obesity cut offs for age and gender.
18 years
Type 2 Diabetes
Time Frame: 18 years
Development of type 2 diabetes defined by diagnostic criteria in the Canadian Diabetes association 2008 guidelines in childhood (≤ 7 years) or adolescence (12-16 years).
18 years

Collaborators and Investigators

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

Sponsor

University of Manitoba

Collaborators

Canadian Institutes of Health Research (CIHR)
Children's Hospital Research Institute of Manitoba

Investigators

  • Principal Investigator: Brandy A Wicklow, MD, MSc, University of Manitoba, Children's Hospital Research Institute of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

September 1, 2013

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2013:227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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