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The Next Generation Longitudinal Birth Cohort Diabetes Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04621396
Acronym
NextGen
Enrollment
600
Registered
2020-11-09
Start date
2013-09-01
Completion date
2028-12-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus, Type 2 Diabetes

Brief summary

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.

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.

Interventions

OTHERObservational screening study

Sponsors

University of Manitoba
Lead SponsorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Children's Hospital Research Institute of Manitoba
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Obesity18 yearsDevelopment of obesity defined by the International task force on obesity cut offs for age and gender.
Type 2 Diabetes18 yearsDevelopment of type 2 diabetes defined by diagnostic criteria in the Canadian Diabetes association 2008 guidelines in childhood (≤ 7 years) or adolescence (12-16 years).

Countries

Canada

Contacts

CONTACTBrandy A Wicklow, MD, MSc
bwicklow@hsc.mb.ca204-787-1222
CONTACTElizabeth AC Sellers, MD, MSc
esellers@hsc.mb.ca204-787-3011
PRINCIPAL_INVESTIGATORBrandy A Wicklow, MD, MSc

University of Manitoba, Children's Hospital Research Institute of Manitoba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026