The Next Generation Longitudinal Birth Cohort Diabetes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational screening study.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Gestational Diabetes Mellitus. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Genetic and Environmental Influences on Development of Type 2 Diabetes in Childhood: The Next Generation Longitudinal Birth Cohort.
Overview
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
- Other Observational screening study
Primary outcome measures
- Obesity [Time frame: 18 years]
- Type 2 Diabetes [Time frame: 18 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Children's Hospital Research Institute of Manitoba/University of Manitoba — Winnipeg
Publications
- Mendelson M, Cloutier J, Spence L, Sellers E, Taback S, Dean H. Obesity and type 2 diabetes mellitus in a birth cohort of First Nation children born to mothers with pediatric-onset type 2 diabetes. Pediatr Diabetes. 2011 May;12(3 Pt 2):219-28. doi: 10.1111/j.1399-5448.2010.00694.x. Epub 2011 Mar 23. PMID 21429061
Identifiers
NCT: NCT04621396 · H2013:227