Intranasal Insulin and Olanzapine Study in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Controls
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This study will follow a single-blind, crossover design wherein each participant will participate in all of the 4 possible treatment combinations (intranasal insulin or intranasal placebo, olanzapine or placebo) including: Intranasal placebo and placebo Intranasal placebo and olanzapine Intranasal insulin and placebo Intranasal insulin and olanzapine Masking: Double (Participant, Investigator)Masking Description: Participants will be masked to: Knowing whether they were assigned to the olanzapine or placebo conditions Knowing whether they were assigned to the intranasal insulin or intranasal placebo conditions. Investigators will only be masked to the randomization of placebo or olanzapine for the participants, but will know whether the participant receives intranasal insulin or intranasal placebo.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 17 years and 45 years
- Gender
- Both males and females
Description
The primary objective of the study is to examine whether a single dose of OLA given to young healthy volunteers during PECs can inhibit the activity of a central insulin stimulus (i.e, INI) to reduce endogenous glucose production. Secondarily, in an exploratory arm, this study seeks to examine wheth...
The primary objective of the study is to examine whether a single dose of OLA given to young healthy volunteers during PECs can inhibit the activity of a central insulin stimulus (i.e, INI) to reduce endogenous glucose production. Secondarily, in an exploratory arm, this study seeks to examine whether a single dose of OLA can inhibit improvements associated with INI administration on specific cognitive domains (visuospatial, and verbal memory). Further, the study will also explore the effects of insulin and OLA on neurochemical and neurohemodynamic measures obtained through MRI imaging techniques. To accomplish these objectives, this study will have two separate and parallel arms - a metabolic PEC arm to study the primary hypothesis, and an MRI imaging and cognitive testing arm to study the two secondary hypotheses.
Tracking Information
- NCT #
- NCT03741478
- Collaborators
- University Health Network, Toronto
- Investigators
- Principal Investigator: Margaret K Hahn, PhD, MD Centre for Addiction and Mental Health Principal Investigator: Satya Dash, MD, PhD University Health Network, Toronto General Hospital
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