NCT04621396

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2013Dec 2028

Study Start

First participant enrolled

September 1, 2013

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

13.3 years

First QC Date

November 3, 2020

Last Update Submit

June 30, 2026

Conditions

Type 2 DiabetesGestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Obesity

    Development of obesity defined by the International task force on obesity cut offs for age and gender.

    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).

    18 years

Study Arms (1)

Next Generation Cohort

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

Other: Observational screening study

Interventions

Observational screening studyOTHER
Next Generation Cohort

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • Mothers or children with type 1 diabetes.
  • Residing outside of Manitoba.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

Related 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.

    PMID: 21429061BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Pregnant women: A1C, lipoprotein profile, adiponectin, leptin, apo A and B, AST, and ALT, and HNF1a status. Birth: HNF1a status, apo 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 infant cord blood. Kidney ultrasound will be done to see the size of the kidney. 1 to 18: creatine, albumin measurements, and urinalysis will be collected every year. Starting at age 2 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. 7 to 18: A1C, OGTT, glucose levels, insulin levels, apolipoprotein A and B, c-reactive protein, lipoprotein profile, ALT, AST, leptin, and adiponectin. Between age 7 and 18: A1C, OGTT, glucose levels will be collected biennially. Blood samples will be frozen to test for biomarkers involved in developing T2D.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, Gestational

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Brandy A Wicklow, MD, MSc

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandy A Wicklow, MD, MSc

CONTACT

204-787-1222bwicklow@hsc.mb.ca

Elizabeth AC Sellers, MD, MSc

CONTACT

204-787-3011esellers@hsc.mb.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Pediatrics and Child Health

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

September 1, 2013

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)