Actively Recruiting

Phase Not Applicable
Age: 17Years - 45Years
All Genders
Healthy Volunteers
NCT05748990

Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia

Led by Centre for Addiction and Mental Health · Updated on 2025-08-05

20

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cognitive impairment (such as challenges in thinking and memory) is a core aspect of schizophrenia (SCZ), contributing to disability and poor functional outcomes. Additionally, almost half of the patients with SCZ are obese, the prevalence of type 2 diabetes is 3-6 times higher, and life expectancy is lower by 15-20 years compared to the general population. This is relevant as metabolic syndrome and diabetes are both associated with worse cognition among SCZ patients. Recent work studying the relationships between metabolic health and cognition has encouraged a new way of thinking about SCZ as both a metabolic and cognitive disorder. Brain insulin is involved in several processes relevant to SCZ, and abnormal brain insulin action may help explain both cognitive and metabolic abnormalities in patients with SCZ, but this has not been examined previously. Glucose uptake in several brain regions relevant to SCZ has been shown to be partially dependent on insulin. Therefore, in this study, the researchers will measure glucose uptake in the brain using an 18F-fluorodeoxyglucose (\[18F\]-FDG) positron emission tomography (PET) scan after an intranasal insulin stimulus, and will compare this measure between patients with SCZ and healthy controls.

CONDITIONS

Official Title

Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia

Who Can Participate

Age: 17Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 17 and 45 years
  • Both sexes included
  • Diagnosis of schizophrenia spectrum disorder confirmed by DSM-5 and chart review
  • First-episode schizophrenia spectrum illness or related psychotic disorders
  • Body mass index (BMI) less than or equal to 27
  • Healthy controls matched by age, sex, hand dominance, and BMI
  • Controls have no DSM-5 diagnosis except specific phobia according to MINI
Not Eligible

You will not qualify if you...

  • Moderate or severe substance use disorder
  • Prediabetes, diabetes, or impaired glucose tolerance
  • Acute suicidal risk
  • Use of weight, lipid, antidiabetic, or blood pressure medications
  • Liver or kidney disease
  • Pregnancy or nursing
  • Presence of pacemakers or metallic cardiac valves
  • Magnetic materials or implants that prevent MRI scanning
  • Significant claustrophobia
  • History of head trauma with loss of consciousness over 30 minutes
  • Physical size or weight preventing MRI or PET scanning
  • Unstable physical illness
  • Significant neurological disorders including seizures
  • Excessive radiation exposure from PET scans
  • More than 6 previous PET scans bringing lifetime total over 8
  • Clinically relevant medical abnormalities
  • Use of medications interfering with study participation or PET imaging
  • Blood clotting disorders or use of anticoagulants
  • For controls: first-degree family history of primary psychotic disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J1H3

Actively Recruiting

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Research Team

M

Mahavir Agarwal, MD, PhD

CONTACT

L

Laurie Hamel, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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