Clinical trial NCT04621396: The Next Generation Longitudinal Birth Cohort Diabetes Study
Official title: Genetic and Environmental Influences on Development of Type 2 Diabetes in Childhood: The Next Generation Longitudinal Birth Cohort.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Gestational Diabetes Mellitus
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 600
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Obesity
timeFrame: 18 years
measure: Type 2 Diabetes
timeFrame: 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Children's Hospital Research Institute of Manitoba/University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba, Children's Hospital Research Institute of Manitoba
name: Brandy A Wicklow, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.