Intranasal Insulin + Olanzapine for Healthy Volunteers
(INI/OLA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how olanzapine, a medication for mental health disorders, affects glucose levels and brain function in healthy volunteers. Researchers will test whether intranasal insulin (insulin taken through the nose) can counteract these effects by improving glucose metabolism and cognitive performance. The study consists of two parts: one focuses on brain scans and cognitive tests, while the other examines glucose processing in the body. Healthy individuals who are not overweight and do not have diabetes might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those using weight-reducing agents or other medications at the discretion of the principal investigator. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that intranasal insulin (INI) is generally safe for humans. Most research indicates no serious side effects at doses up to 160 IU. Some individuals might experience mild nose irritation, but no severe side effects, such as low blood sugar, have been reported.
For olanzapine, studies suggest it is generally safe, though it can cause some side effects. Common issues include weight gain and drowsiness. More serious side effects are rare but possible, so monitoring during use is important.
Both treatments have undergone testing in various studies, and while side effects can occur, they are usually manageable and not severe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about intranasal insulin and olanzapine in combination because they offer unique approaches to understanding and potentially enhancing brain and metabolic functions. Unlike typical treatments for cognitive and metabolic conditions that often rely on oral medications, this research explores a novel delivery method: intranasal administration of insulin, which directly targets the brain and may enhance cognitive performance. Additionally, olanzapine, a well-known antipsychotic, is being studied for its effects when combined with insulin to understand its impact on metabolism and brain activity. This trial could reveal new insights into how these substances can be used together to improve cognitive and metabolic outcomes.
What evidence suggests that this trial's treatments could be effective for glucose metabolism and cognitive performance?
This trial will examine the effects of intranasal insulin and olanzapine in healthy volunteers. Research has shown that insulin administered via nasal spray can enhance memory and learning. About half of the studies reported significant improvements in cognitive skills, particularly in word recall and visual information processing. This method delivers insulin directly to the brain, aiding in the regulation of memory and thinking functions.
In this trial, participants in the Cognitive and MRI Arm will receive either olanzapine or a placebo, followed by intranasal insulin or a saline placebo, to evaluate cognitive effects and brain imaging results. Meanwhile, participants in the Metabolic Arm will receive either olanzapine or a placebo, followed by intranasal insulin or a saline placebo, during a pancreatic euglycemic clamp procedure to investigate metabolic effects. Olanzapine, a medication used to alleviate schizophrenia symptoms and improve social interactions, can cause side effects like weight gain and may impact sugar metabolism, potentially leading to insulin resistance. Researchers aim to understand how olanzapine interacts with insulin delivered through a nasal spray.23678Who Is on the Research Team?
Satya Dash, MD, PhD
Principal Investigator
University Health Network, Toronto General Hospital
Margaret K Hahn, PhD, MD
Principal Investigator
Centre for Addiction and Mental Health
Are You a Good Fit for This Trial?
This trial is for healthy, non-obese individuals aged 17-45 (Cognitive Arm) or 17-65 (Metabolic Arm). Exclusions include left-handedness (for Cognitive/MRI arm), pre-diabetes/diabetes, family history of diabetes, liver/kidney disease, major recent medical events, pregnancy/breastfeeding, psychiatric illness history (except certain anxiety disorders in Metabolic Arm), and conditions unsafe for MRI.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cognitive and MRI Arm
Participants undergo MRI scans and cognitive testing across 4 visits, with administration of Olanzapine or placebo and intranasal insulin or saline placebo
Metabolic Arm
Participants undergo pancreatic euglycemic clamp procedures across 3 visits, with administration of Olanzapine or placebo and intranasal insulin or saline placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intranasal Insulin
- Olanzapine
Trial Overview
The study tests the effects of intranasal insulin on glucose production and cognitive performance in healthy volunteers. It examines whether olanzapine alters these effects. Participants receive either insulin or placebo nasally and are monitored using a pancreatic euglycemic clamp procedure and MRI imaging techniques.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
This arm includes a screening visit 1 and screening visit 2 to assess eligibility. This arm then includes the pancreatic euglycemic clamp procedure at visits 1 to 3. Visits 1 to 3 each consist of 3 days (day 0, day 1, and day 2). Olanzapine 2.5mg (or placebo) will be administered in doses of 5mg on day 0, 7.5mg on day 1, and 10mg on day 2. Day 2 consists of the final dose of olanzapine (or placebo) and the pancreatic euglycemic clamp procedure and other assessment procedures. On day 2, the participant is also randomized to and administered either intranasal insulin/Insulin Lispro 100 UNT/ML (or saline placebo) during the pancreatic euglycemic clamp procedure.
This arm includes a screening visit 1 and screening visit 2 to assess eligibility. This arm includes an MRI scan and cognitive testing at visits 1 to 4. Visits 1 to 4 each consist of 3 days (day 0, day 1, and day 2). Olanzapine 2.5mg (or placebo) will be administered in doses of 5mg on day 0, and 10mg on day 1. Cognitive testing and MRI scanning then occur on day 2. On day 2, the participant is also randomized to and administered either intranasal insulin/Insulin Lispro 100 UNT/ML (or saline placebo) prior to conducting the MRI imaging and cognitive testing.
Intranasal Insulin is already approved in United States, European Union for the following indications:
- Diabetes
- Diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor
University Health Network, Toronto
Collaborator
Citations
High‐dose intranasal insulin in an adaptive dose‐escalation ...
There are substantial clinical safety data for intranasal insulin in human trials, but there are no data suggesting the maximum tolerated dose.
Intranasal Insulin Therapy for Cognitive Impairment and ... - PMC
Treatment with intranasal insulin prevented the brain morphological abnormalities, white matter loss, and impairments in signaling through survival and synaptic ...
NCT05062785 | Dose-Finding Study of Intranasal Insulin in ...
This study is to determine the safety and tolerability of regular insulin (Humulin R) when given intranasally (as drops in nostrils). Healthy participants will ...
4.
alzdiscovery.org
alzdiscovery.org/uploads/cognitive_vitality_media/Intranasal-insulin-Cognitive-Vitality-For-Researchers.pdfIntranasal-insulin-Cognitive-Vitality-For- ...
Of the 16 includes trials that assessed cognitive outcomes, 50% of the trials reported a significant effect of intranasal insulin on at least one cognitive ...
Intranasal Insulin for the Treatment of Mild Cognitive ...
Intranasal insulin was generally safe, with no differences in AE profiles between the insulin and placebo arms. This observation is consistent ...
Safety of intranasal human insulin: A review
No cases of symptomatic hypoglycaemia or severe adverse events (AEs) were reported. Transient local side effects in the nasal area were frequently experienced ...
Safety of intranasal insulin administration in patients ...
The maximum safe dose during surgery is 160 IU. Higher doses can cause hypoglycemia due to absorption of insulin into the blood.
Therapeutic effects of intranasally-administered insulin (INI ...
Safety data were reviewed semi-annually by a Data and Safety Monitoring Board. Adverse event reporting followed standard guidelines. 3.4.
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