← Back to Search

Hormone Therapy

Intranasal Insulin Effects in Healthy Subjects

Phase 1
Waitlist Available
Led By Florian Schmitzberger, MD
Research Sponsored by Florian Schmitzberger
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to lie flat for a minimum of 2-hours
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline fmri (approximately 30 minutes), fmri approximately 30 minutes (after insulin dose administration)
Awards & highlights

Study Summary

This trial studies brain response using MRI before & after insulin doses, measuring activity & blood flow in the brain.

Who is the study for?
This trial is for healthy adults with a BMI between 18 and 35 who can lie flat for at least 2 hours. Women must be non-pregnant, surgically sterilized, or postmenopausal. Participants should be willing to stay at the research facility as required and comply with study procedures.Check my eligibility
What is being tested?
The trial is testing how different doses of insulin administered through the nose affect brain activity. This is measured using functional MRI (fMRI), which tracks blood flow and metabolism changes in the brain after treatment.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from lying still during fMRI scans, nasal irritation from intranasal insulin delivery, or rare systemic effects of insulin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can lie flat for at least 2 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline fmri (approximately 30 minutes), fmri approximately 30 minutes (after insulin dose administration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline fmri (approximately 30 minutes), fmri approximately 30 minutes (after insulin dose administration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Signal response using fMRI after administration of intranasal insulin
Secondary outcome measures
Change in Blood Glucose (serum or point of care capillary)

Side effects data

From 2013 Phase 2 trial • 30 Patients • NCT01206322
7%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diabetes Group: Placebo
Control Group: Insulin
Diabetes Group: Insulin
Control Group: Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intranasal insulin and placeboExperimental Treatment1 Intervention
A total of 3 possible doses will be tested of insulin 0 units (u) (placebo (diluent), 500u, and 1000u. The order that participants will receive these doses will be in a random order.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intranasal insulin
2006
Completed Phase 2
~190

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Florian SchmitzbergerLead Sponsor
Florian Schmitzberger, MDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being examined in this research initiative?

"Yes, according to the data housed on clinicaltrials.gov, this trial is presently recruiting participants and has been since November 1st 2023. Most recently updated on the 16th of that same month, it requires 6 individuals from one location for completion."

Answered by AI

Are there any vacancies in this research endeavor for new participants?

"Affirmative, the information available on clinicaltrials.gov points to this trial actively searching for participants. It was first advertised on November 1st 2023 and updated most recently on November 16th of that year. The researchers are looking for 6 individuals at a single medical facility."

Answered by AI

What potential perils are associated with Intranasal insulin?

"Intranasal insulin has a safety score of 1 due to the lack of clinical evidence that supports its efficacy and limited data attesting to its safety."

Answered by AI

Who else is applying?

What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

The clinic is close by.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI)
Florian Schmitzberger 2023. "Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144255.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top