The Next Generation Longitudinal Birth Cohort Diabetes Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Mothers or children with type 1 diabetes.
Residing outside of Manitoba.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational screening study
Other intervention
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Next Generation Cohort1 intervention
Trial outcomes
Primary outcomes
1
Obesity
Development of obesity defined by the International task force on obesity cut offs for age and gender.
Time frame
18 years2
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).
Time frame
18 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manitoba
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Children's Hospital Research Institute of Manitoba
Collaborator
Source ClinicalTrials.gov