The Next Generation Longitudinal Birth Cohort Diabetes Study

Type 2 Diabetes Clinical Trial

— NextGen  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04621396
• Other study ID #: H2013:227
• Status: Recruiting
• Start date: September 2013
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: University of Manitoba
• Contact: Brandy A Wicklow, MD, MSc
• Phone: 204-787-1222
• Email: bwicklow[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2028
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Type 2 Diabetes

Intervention

Other:
• Observational screening study

Locations

Country	Name	City	State
Canada	Children's Hospital Research Institute of Manitoba/University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity	Development of obesity defined by the International task force on obesity cut offs for age and gender.	18 years
Primary	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

External Links

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