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Neurologic DisorderNCT04098679

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

An observational study of Neurologic Disorder and Adiposity, run by University of Calgary at 4 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Neurologic Disorder, Adiposity
How many people
174 participants
Where
4 sitesCanada
Study dates
30 Sep 2019to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

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 3 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Participants, aged 3 to 7 years

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Sonya Mergler, BA contact

416-480-5627

conceptt@sunnybrook.ca

Gail Klein, MSc contact

416-480-5632

gail.klein@sunnybrook.ca

Canada4 sites, 4 recruiting

  • University of Calgary

    Calgary, Alberta, T2T 5C7

    Lois Donovan, MD FRCPC, 403 955-8358

    Lois Donovan, MD FRCPC

    Recruiting

  • Lawson Health Research Institute

    London, Ontario

    Selina Lui

    Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario

    Denice Feig

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

    Ilana Halperin

    Recruiting

Other trials in Canada

About this study

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

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.

Read the 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.

Keywords
Type 1 diabetes, Offspring, Continuous glucose monitoring
Medical subject headings
Nervous System Diseases, Obesity, Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IQ

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

    Measured: 2 years

Secondary outcomes (6)

  1. ADHD

    Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV and Attention Deficit Hyperactive Disorder Rating Scale-IV Preschool Version. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms. The respondent rates each item on a scale of 0 (not at all) to 3 (very often).

    The scale yields scores for an Inattentive, Hyperactive/Impulsive and Total Scale. The subscales are Inattention Factor and Hyperactive/Impulsive Factor.

    Measured: 2 years

  2. ASD

    Social Responsiveness Scale-2 questionnaire results for Autism Spectrum Disorder behaviours. It is an 65-item questionnaire that requires the respondent to describe the child's behaviour. The respondent rates each item on a scale of 1 (not true) to 4 (almost always true). The scale yields scores for autism spectrum disorders for total score discussion of social behaviour and social interactions.

    Measured: 2 years

  3. NEPSY-II

    The NEPSY-II stands for "A Developmental NEuroPSYchological Assessment". Children's language skills assessed using the Speed Naming and Phonological Processing subscales of the NEPSY-II testing results. Phonological Processing is a subtest composed of phonological processing tasks designed to assess phonemic awareness. Speed Naming is a timed subtest designed to assess rapid semantic access to and production of names of colors, shapes, sizes, letters, or numbers.

    Measured: 2 years

  4. CCC-2/LUI

    Parent reported language development on the Children's Communication Checklist-2 (CCC_2) for children over four years of age or the Language Use Inventory (LUI) for children 36 to 47 months of age questionnaire results. The Children's Communication Checklist - Seconda Edition has 70 Statements that refer to difficulties children may have that affect their ability to communicate. Rating key is 0 (less than once a week or never) to 3 (several times, more than twice, a day, or always). Total score is used.

    Measured: 2 years

  5. Demographics

    Data form to be completed by parents will ask about their level of education, sex, gender, socioeconomic status, height, and any neurodevelopmental or other medical diagnoses in their enrolled child

    Measured: 2 years

  6. Adiposity

    Childhood adiposity measures: 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 using standardized procedures

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start30 Sep 2019
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098679
Sponsor's protocol ID
REB14-2146_MOD2
Status last verified
Sep 2022
First submitted
19 Sep 2019
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan for individual level data to be shared with other researchers

Publications

  • 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.

    PubMed 28923465

Questions about this trial

What is this clinical trial studying?

An observational study of Neurologic Disorder and Adiposity, run by University of Calgary at 4 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sonya Mergler, BA (416-480-5627, conceptt@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IQ (time frame: 2 years). 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 NCT04098679, 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 3 Oct 2022.

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