The Next Generation Longitudinal Birth Cohort Diabetes Study

NCT ID: NCT04621396

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Gestational Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Next Generation Cohort

We will follow the children from mothers who either have T2D, GDM, or are controls.

Observational screening study

Intervention Type OTHER

Interventions

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Observational screening study

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Brandy Wicklow

Assistant Professor, Pediatrics and Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandy A Wicklow, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba, Children's Hospital Research Institute of Manitoba

Locations

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Children's Hospital Research Institute of Manitoba/University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Brandy A Wicklow, MD, MSc

Role: CONTACT

204-787-1222

Elizabeth AC Sellers, MD, MSc

Role: CONTACT

204-787-3011

Facility Contacts

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Brandy A Wicklow, MD, MSc

Role: primary

204781222

References

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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.

Reference Type BACKGROUND
PMID: 21429061 (View on PubMed)

Related Links

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https://www.dreamdiabetesresearch.com/

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

Other Identifiers

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H2013:227

Identifier Type: -

Identifier Source: org_study_id

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