The Next Generation Longitudinal Birth Cohort Diabetes Study (NextGen)
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|ClinicalTrials.gov Identifier: NCT04621396|
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Gestational Diabetes Mellitus||Other: Observational screening study|
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:
- Maternal and/or paternal factors including anthropometrics, metabolic parameters, HNF1a genotype, lifestyle (diet and physical activity), and socioeconomic environment.
- Infant factors including anthropometrics, early infant nutrition, and metabolism.
- To evaluate if children born to mothers with T2D prior o pregnancy are at increased risk of obesity and T2D.
- To determine the modifiable risk factors which contribute to the increased risk of obesity and T2D.
- 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.
- 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.
- 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|
|Estimated Enrollment :||600 participants|
|Official Title:||Genetic and Environmental Influences on Development of Type 2 Diabetes in Childhood: The Next Generation Longitudinal Birth Cohort.|
|Actual Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 2024|
Next Generation Cohort
We will follow the children from mothers who either have T2D, GDM, or are controls.
Other: Observational screening study
- Obesity [ Time Frame: 18 years ]Development of obesity defined by the International task force on obesity cut offs for age and gender.
- Type 2 Diabetes [ Time Frame: 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).
Biospecimen Retention: Samples With DNA
For pregnant women: hemoglobin A1C, fasting lipid panel, adiponectin, leptin, apolipoprotein A and B, AST, and ALT, and HNF1a carrier status.
At birth: In offspring: HNF1a status, apolipoprotein A and B, glucose, insulin, c-peptide, and free fatty acid, leptin, and adiponectin, c-reactive protein (CRP), cytokines (interleukins and TNF alpha) will be tested on cord blood.
age 1 to18 - creatine, albumin measurements, and urinalysis. Also, starting at age 6 and every 2 years afterward, urine will be frozen to test for biomarkers that may predict kidney damage or uncover causes for kidney damage in the future.
age 7 to 18 - hemoglobin A1C, blood glucose levels, insulin levels, apolipoprotein A and B, c-reactive protein, lipoprotein profile, ALT, AST, leptin, and adiponectin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621396
|Contact: Brandy A Wicklow, MD, MScemail@example.com|
|Contact: Elizabeth AC Sellers, MD, MScfirstname.lastname@example.org|
|Children's Hospital Research Institute of Manitoba/University of Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada, R3E 3P4|
|Contact: Brandy A Wicklow, MD, MSc 204781222 email@example.com|
|Principal Investigator:||Brandy A Wicklow, MD, MSc||University of Manitoba, Children's Hospital Research Institute of Manitoba|