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NCT Number: NCT04621396

The Next Generation Longitudinal Birth Cohort Diabetes Study

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Winnipeg, Manitoba, R3E 3P4, Canada

Location status: Recruiting

Location contact

Brandy A Wicklow, MD, MSc

CONTACT

[email protected]

204781222

About this study

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:

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

Secondary Objectives:

  • To evaluate if children born to mothers with T2D prior o pregnancy are at increased risk of obesity and T2D.
  • To determine the modifiable risk factors which contribute to the increased risk of obesity and T2D.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Observational screening study

Other

Primary outcomes

  1. Obesity

    Time frame: 18 years

    Development of obesity defined by the International task force on obesity cut offs for age and gender.

  2. 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).

Study contacts

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

Brandy A Wicklow, MD, MSc

CONTACT

[email protected]

204-787-1222

Elizabeth AC Sellers, MD, MSc

CONTACT

[email protected]

204-787-3011

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NextGen

Important dates

Study start
2013
Primary completion
2026
Study completion
2028
First posted
Nov 9, 2020
Registry last updated
Jul 2, 2026

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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