Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)

NCT04098679 | Unknown

• 1 other identifier: REB14-2146_MOD2
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 4

Brief Summary

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy). The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.

Conditions

Neurologic Disorder; Adiposity

Keywords

Type 1 diabetes; Offspring; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• IQ

  IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)

  2 years

Secondary Outcomes (6)

• ADHD

  2 years

• ASD

  2 years

• NEPSY-II

  2 years

• CCC-2/LUI

  2 years

• Demographics

  2 years

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants, aged 3 to 7 years

You may qualify if:

• Children of women who participated in the CONCEPTT trial at selected recruiting sites.

You may not qualify if:

• Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.

Sponsors & Collaborators

• University of Calgary: lead
• SRI International: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (4)

University of Calgary

Calgary, Alberta, T2T 5C7, Canada

RECRUITING

Lawson Health Research Institute

London, Ontario, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.

  PMID: 28923465 RESULT

MeSH Terms

Conditions

Nervous System Diseases; Obesity; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jennifer Yamamoto, MD MSc FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonya Mergler, BA

CONTACT

416-480-5627; conceptt@sunnybrook.ca

Gail Klein, MSc

CONTACT

416-480-5632; gail.klein@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 30, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)