Clinical trial NCT04098679: Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes (CONCEPTT Kids)
Official title: CONCEPTT Kids Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurologic Disorder
Adiposity
Keywords: Type 1 diabetes
Offspring
Continuous glucose monitoring
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: SRI International
name: Juvenile Diabetes Research Foundation
First posted: 2019-09-23
Enrollment: 174
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants, aged 3 to 7 years

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.

Detailed description: The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated.

The other procedures will include:

1. the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (1);
2. ADHD Rating Scale IV (2) and ADHD Rating Scale-IV Preschool Version (3);
3. Social Responsiveness Scale-2 for ASD behaviours (4);
4. Children's performance on the Speed Naming and Phonological Processing subscales of the NEPSY-II (5)
5. Parent reported language development on the Children's Communication Checklist-2 for children over four years of age (6) or the Language Use Inventory (LUI) for children 36 to 47 months of age (7).

Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: IQ
timeFrame: 2 years
Secondary outcomes:
measure: ADHD
timeFrame: 2 years
measure: ASD
timeFrame: 2 years
measure: NEPSY-II
timeFrame: 2 years
measure: CCC-2/LUI
timeFrame: 2 years
measure: Demographics
timeFrame: 2 years
measure: Adiposity
timeFrame: 2 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Calgary
name: Jennifer Yamamoto, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.