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The Next Generation Longitudinal Birth Cohort Diabetes Study (NextGen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621396
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Brandy Wicklow, University of Manitoba

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Gestational Diabetes Mellitus Other: Observational screening study

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:

  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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Next Generation Cohort
We will follow the children from mothers who either have T2D, GDM, or are controls.
Other: Observational screening study



Primary Outcome Measures :
  1. Obesity [ Time Frame: 18 years ]
    Development of obesity defined by the International task force on obesity cut offs for age and gender.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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).

Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Brandy A Wicklow, MD, MSc 204-787-1222 bwicklow@hsc.mb.ca
Contact: Elizabeth AC Sellers, MD, MSc 204-787-3011 esellers@hsc.mb.ca

Locations
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Canada, Manitoba
Children's Hospital Research Institute of Manitoba/University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Brandy A Wicklow, MD, MSc    204781222    bwicklow@hsc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Brandy A Wicklow, MD, MSc University of Manitoba, Children's Hospital Research Institute of Manitoba
Additional Information:
Publications:
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Responsible Party: Dr. Brandy Wicklow, Assistant Professor, Pediatrics and Child Health, University of Manitoba
ClinicalTrials.gov Identifier: NCT04621396    
Other Study ID Numbers: H2013:227
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications