Intranasal Insulin and Olanzapine Study in Healthy Volunteers
This study is investigating a medicine called olanzapine, which is used for mental health conditions but can sometimes cause weight gain and affect how the body handles sugar. Researchers want to see how olanzapine impacts blood sugar levels and thinking skills in healthy volunteers. They are also testing if a special nasal spray containing insulin can help counteract these effects or improve brain function. The goal is to understand how these medicines work in the body and brain, particularly how they might influence sugar control and cognitive abilities, to help develop better treatments in the future.
At a glance
What is this study about?
Antipsychotic medicines, like olanzapine, are really important for treating serious mental health conditions. However, many people who take them experience side effects such as weight gain and an increased risk of developing type 2 diabetes. These side effects can be particularly concerning for younger individuals.
This study is trying to understand why these side effects happen. Researchers believe that the way insulin works in the brain might play a role in how the body handles sugar, and also in how we think and remember things. Previous studies in animals suggested that olanzapine might interfere with how insulin in the brain helps control blood sugar. This study aims to see if the same thing happens in healthy people.
We also know that giving insulin through a nasal spray has been shown to improve memory and other thinking skills in some people. This study will explore whether olanzapine affects this positive impact of nasal insulin on brain function. By understanding these interactions, scientists hope to find ways to reduce the side effects of important medicines and improve treatment for patients in the future.
Key takeaways
- This study is for healthy volunteers aged 17-65.
- It investigates how olanzapine affects blood sugar and thinking.
- It also tests if a nasal insulin spray can help.
- Participation may involve blood tests, medicine, and brain scans.
- The goal is to improve understanding of medicine side effects.
Who may be eligible?
This study is looking for healthy volunteers to take part. For the part of the study focused on understanding how your body processes sugar, you need to be between 17 and 65 years old. If you're interested in the part of the study that looks at thinking skills and uses special brain scans (MRI), you need to be between 17 and 45 years old, and you must be right-handed.
There are certain conditions that would mean you can't join. This includes if you have ever had a mental health illness, although for the sugar-processing part of the study, some anxiety disorders may be allowed. You also can't have pre-diabetes, diabetes, a family history of diabetes, or any problems with your liver or kidneys. Pregnant or breastfeeding individuals cannot participate, nor can anyone who has had a major illness or surgery recently.
If you're considering the brain scan part of the study, you cannot have any metal implants in your body (like a pacemaker) or suffer from claustrophobia (a fear of enclosed spaces), as these would make MRI scans unsafe or impossible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 17 and 65 years old?
- Do you consider yourself generally healthy, without diabetes or serious illnesses?
- Are you not currently pregnant or breastfeeding?
- Do you not have any metal implants (for the brain scan part)?
- Are you right-handed (for the brain scan part)?
What does participation involve?
If you join this study, you might take part in one of two main parts: one focusing on how your body handles sugar, and another looking at your brain's activity and thinking skills. Some volunteers might participate in both. You'll receive either a single dose of the medicine olanzapine, a placebo (a dummy pill), a nasal spray of insulin, or a saline (saltwater) nasal spray.
The sugar-handling part of the study involves a special procedure called a pancreatic euglycemic clamp (PEC), which will carefully measure how your body processes sugar. The brain activity part involves MRI scans and tests of your memory and thinking skills. The total duration of your participation, including the number of visits and follow-up, will be explained in detail by the study team, but generally involves a few visits to the clinic.
Potential risks and benefits
Locations (2)
- University Health Network - Toronto General HospitalVerified postcodeToronto, Canada
- Center for Addiction and Mental HealthVerified postcodeToronto, Canada
Common questions
What is olanzapine?
Olanzapine is a medicine often used to treat mental health conditions, but it can have side effects like weight gain.
What is intranasal insulin?
This is insulin given as a nasal spray, and it's being studied for its effects on the brain and thinking skills.
Why are healthy volunteers needed?
Studying healthy volunteers helps researchers understand how medicines work in the body without other health conditions making the results unclear.
Will I know if I'm getting the real medicine or a placebo?
No, this is a 'blinded' study, meaning neither you nor the researchers will know who gets which treatment until after the study is over, to keep the results fair.
What is a 'pancreatic euglycemic clamp'?
It's a special medical procedure that precisely measures how your body manages blood sugar and insulin levels.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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