The Next Generation Longitudinal Birth Cohort Diabetes Study (NextGen)

University of Manitoba

Status: Enrolling

Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes

Treatments: Other: Observational screening study

Study type: Observational

Funder types: Other

Identifiers

NCT04621396

H2013:227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Next Generation Cohort

Description:

We will follow the children from mothers who either have T2D, GDM, or are controls.

Treatment:

Other: Observational screening study