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Clinical Trials/NCT04621396
NCT04621396
Recruiting
Not Applicable

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

University of Manitoba1 site in 1 country600 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Manitoba
Enrollment
600
Locations
1
Primary Endpoint
Obesity
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Brandy Wicklow

Assistant Professor, Pediatrics and Child Health

University 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.

Outcomes

Primary Outcomes

Obesity

Time Frame: 18 years

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

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 Sites (1)

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