The Next Generation Longitudinal Birth Cohort Diabetes Study

Recruiting

• Conditions: Type 2 Diabetes; Gestational Diabetes Mellitus
• Interventions: Other: Observational screening study

• Registration Number: NCT04621396
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2026-12-31
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Next Generation Cohort	Observational screening study	We will follow the children from mothers who either have T2D, GDM, or are controls.

Primary Outcome Measures

Name	Time	Method
Obesity	18 years	Development of obesity defined by the International task force on obesity cut offs for age and gender.
Type 2 Diabetes	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).

Trial Locations

Locations (1)

Children's Hospital Research Institute of Manitoba/University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada