The Next Generation Longitudinal Birth Cohort Diabetes Study (NextGen)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Gestational Diabetes Mellitus
• Intervention / Treatment: Other: Observational screening study

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Brandy A Wicklow, MD, MSc; Phone Number: 204-787-1222; Email: bwicklow@hsc.mb.ca
• Study Contact Backup: Name: Elizabeth AC Sellers, MD, MSc; Phone Number: 204-787-3011; Email: esellers@hsc.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Recruiting
      • Children's Hospital Research Institute of Manitoba/University of Manitoba
      • Contact: Brandy A Wicklow, MD, MSc; Phone Number: 204781222; Email: bwicklow@hsc.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Brandy A Wicklow, MD, MSc, University of Manitoba, Children's Hospital Research Institute of Manitoba

Publications and helpful links

General 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.

Helpful Links

• Website that has all the current projects that deal with diabetes.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational
• Other Study ID Numbers: H2013:227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No