Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT04032639

Conditions

Prader-Willi Syndrome

Eligibility Criteria

Sex: All

Age: 7 - 16

Healthy Volunteers: Accepted

Study Details

Brief summary:

Individuals with Prader-Willi Syndrome (PWS) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges. In addition, some patients with PW been shown to have low cortisol production, particularly in stressful situations. However, research examining how hormonal, cognitive, and psychological factors are interrelated PWS is limited. To address this gap in knowledge, the goal of this project is to understand how changes in brain regions involved in controlling food intake and cognitive processes are related to changes in hormones regulating appetite, the stress hormone cortisol, and performance on neuropsychological tests.

Conditions

Prader-Willi Syndrome

Study ID

NCT04032639

Start date

May 30, 2019

Status verified date

Sep, 2022

Completion date

May, 2024

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 16

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Genetically diagnosed PWS (study population)
  • Adolescents matched for age, sex, and BMI-percentile (controls)

Exclusion Criteria:

  • Past or current history of alcoholism or consistent drug use
  • Current untreated major psychiatric illness as defined by the DSM-V criteria
  • Medications that decrease alertness (that cannot be held on the days of testing)
  • History of recent major head trauma
  • Current pregnancy
  • Diagnosis of diabetes
  • Current or recent smoker (i.e. >2 cigarettes/week during past year)
  • History of metal in body (shrapnel, metal slivers, unremovable metal adornments, clips, top braces, pacemaker)
  • Use of glucocorticoid medications

Study Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Arms

Prader-Willi Syndrome

24 children and adolescents (7-16 years) with diagnosed Prader-Willi Syndrome will be recruited

Controls

24 children and adolescents (7-16 years) without diagnosed Prader-Willi Syndrome will be matched for age, sex, and BMI-percentile to the Prader-Willi group

Primary outcome measure

  • Neuronal activity during the food cue reactivity task [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jill K Hamilton, MD

416-813-5115jill.hamilton@sickkids.ca

Barkha Patel, PhD

416-813-7654barkha.patel@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Contacts

Barkha Patel, PhD

416-813-7654barkha.patel@sickkids.ca

Principal Investigator:

Jill Hamilton, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Jill Hamilton, MD

(416) 913-5115jill.hamilton@sickkids.ca

Principal Investigator:

Jill Hamilton, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Sep 13, 2022

Last verified

Sep, 2022

Keywords

  • Prader-Willi Syndrome
  • Magnetoencephalography
  • Food Cue Reactivity
  • Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2022-09-13.