Type 2 DiabetesNextGenNCT04621396
The Next Generation Longitudinal Birth Cohort Diabetes Study
An observational study of Type 2 Diabetes and Gestational Diabetes Mellitus, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Gestational Diabetes Mellitus
- What is being tested?
- Observational screening study
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- Mothers or children with type 1 diabetes.
- Residing outside of Manitoba.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital Research Institute of Manitoba/University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Brandy A Wicklow, MD, MSc, 204781222, bwicklow@hsc.mb.ca
About this study
Official title: 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.
Read the 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:
- 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.
Secondary Objectives:
- 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.
- Conditions
- Type 2 Diabetes, Gestational Diabetes Mellitus
- Being tested
- Observational screening study
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational screening studyOther
| Study group | Role | What they receive |
|---|---|---|
| Next Generation Cohort | We will follow the children from mothers who either have T2D, GDM, or are controls. Receives: Other: Observational screening study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
Development of obesity defined by the International task force on obesity cut offs for age and gender.
Measured: 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).
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study startSep 2013
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital Research Institute of Manitoba
- Responsible party
- Principal investigator, Dr. Brandy Wicklow, University of Manitoba
- Investigators
- Brandy A Wicklow, MD, MSc, Principal investigator, University of Manitoba, Children's Hospital Research Institute of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621396
- Sponsor's protocol ID
- H2013:227
- Acronym
- NextGen
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21429061
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Environmental Influences on Development of Type 2 Diabetes in Childhood: The Next Generation Longitudinal Birth Cohort.
- ClinicalTrials.gov ID
- NCT04621396
- Acronym / sponsor ID
- NextGen / H2013:227
- Conditions
- Type 2 Diabetes, Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital Research Institute of Manitoba
- Study start
- Sep 2013 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Secondary Objectives:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Next Generation Cohort | – | Other: Observational screening studyWe will follow the children from mothers who either have T2D, GDM, or are controls. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Mothers or children with type 1 diabetes.
- Residing outside of Manitoba.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational screening study | Other | Next Generation Cohort |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 21429061Mendelson 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.
- Website that has all the current projects that deal with diabetes.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandy A Wicklow, MD, MSc principal investigator
University of Manitoba, Children's Hospital Research Institute of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Gestational Diabetes Mellitus, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandy A Wicklow, MD, MSc (204-787-1222, bwicklow@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity (time frame: 18 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.