HealthyPhase 1NCT06144255
Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI)
A Phase 1 study testing Intranasal insulin in people with Healthy, run by Florian Schmitzberger at 1 site in United States.
Trial summary
The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intranasal insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to 22 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in good health based on medical history, physical exam, and routine laboratory testing
- Female participants must have a negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 years with the absence of menses for greater than 12 months.
- Body mass index (BMI) between 18 kg/m2 and 35 kg/m2
- Willing and able to stay at the clinical research facility as required by the protocol
- Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
- Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
- Ability to lie flat for a minimum of 2-hours
Who cannot join
- Known allergy to insulin.
- Preexisting diabetes.
- Current or previous use of diabetes medication or insulin.
- Any nasal disease or congestion that may interfere with intranasal drug absorption.
- Baseline hypoglycemia (blood glucose ≤ 65 milligrams per deciliter (mg/dL)) or hyperglycemia (blood glucose > 200 mg/dL) as evident from the screening labs.
- Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness
Show all 12Show fewer
- Treated with an investigational drug within 30 days.
- Individuals with inadequate venous access.
- Claustrophobic, uncontrollable shaking, or unable to lie still for a lengthy period.
- Any metals or implanted devices within the body.
- Any foreign metallic objects in the body.
- Females that are pregnant, trying to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional MRI
The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. It becomes a functional MRI when the study team looks at the activity within the brain (blood flow / change in metabolism).
Read the detailed description
If cardiac arrest is not treated immediately, it causes sudden death. Intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest or other brain injury. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin reduces brain injury in animal experiments and has been used to try to improve brain degeneration in patients with Alzheimer's disease in doses up to 160 units.
- Conditions
- Healthy
- Being tested
- Intranasal insulin
- Keywords
- Healthy Participants, Intranasal Insulin, Functional Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal insulinDrug
Also called HUMULIN R U-500
Enrolled Participants for this trial will come for 3 study visits. The doses will be administered in varying order: participants will be randomized to one six possible permutations of the intranasal study doses (0, 500, 1000 U) of intranasal insulin at each visit.
Participants will undergo a fMRI scan before and after receiving intranasal doses. Additionally, participants will have blood samples taken.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal insulin and placebo | Experimental | 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. Receives: Drug: Intranasal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Signal response using fMRI after administration of intranasal insulin
Values of regions of interest in the fMRI will be calculated for all measures, including cerebral blood flow (CBF), at different used dosages and compared directly as well as with baseline-corrected CBF maps. The study team will determine if a significant difference at different dosages exists.
Measured: Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration)
Secondary outcomes (1)
Change in Blood Glucose (serum or point of care capillary)
Measured: Baseline (Immediately before drug administration), up to approximately 90 minutes (after drug dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start17 Nov 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each volunteer will have 3 study visits, receiving a different study dose at each visit in randomized order as spelled out in the protocol.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florian Schmitzberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Florian Schmitzberger, University of Michigan
- Investigators
- Florian Schmitzberger, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144255
- Sponsor's protocol ID
- HUM00230748
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional MRI
- ClinicalTrials.gov ID
- NCT06144255
- Acronym / sponsor ID
- HUM00230748
- Conditions
- Healthy
- Keywords
- Healthy Participants, Intranasal Insulin, Functional Magnetic Resonance Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Florian SchmitzbergerUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. It becomes a functional MRI when the study team looks at the activity within the brain (blood flow / change in metabolism).
Detailed description
If cardiac arrest is not treated immediately, it causes sudden death. Intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest or other brain injury. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin reduces brain injury in animal experiments and has been used to try to improve brain degeneration in patients with Alzheimer's disease in doses up to 160 units.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each volunteer will have 3 study visits, receiving a different study dose at each visit in randomized order as spelled out in the protocol.
| Arm | Type | Receives |
|---|---|---|
| Intranasal insulin and placebo | Experimental | Drug: Intranasal insulinA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants in good health based on medical history, physical exam, and routine laboratory testing
- Female participants must have a negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 years with the absence of menses for greater than 12 months.
- Body mass index (BMI) between 18 kg/m2 and 35 kg/m2
- Willing and able to stay at the clinical research facility as required by the protocol
- Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
Key exclusion criteria (12 listed)
- Known allergy to insulin.
- Preexisting diabetes.
- Current or previous use of diabetes medication or insulin.
- Any nasal disease or congestion that may interfere with intranasal drug absorption.
- Baseline hypoglycemia (blood glucose ≤ 65 milligrams per deciliter (mg/dL)) or hyperglycemia (blood glucose > 200 mg/dL) as evident from the screening labs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal insulinAlso: HUMULIN R U-500Enrolled Participants for this trial will come for 3 study visits. The doses will be administered in varying order: participants will be randomized to one six possible permutations of the intranasal study doses (0, 500, 1000 U) of intranasal insulin at each visit. Participants will undergo a fMRI scan before and after receiving intranasal doses. Additionally, participants will have blood samples taken. | Drug | Intranasal insulin and placebo |
Primary outcome
Change in Signal response using fMRI after administration of intranasal insulin
Time frame: Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration)
Values of regions of interest in the fMRI will be calculated for all measures, including cerebral blood flow (CBF), at different used dosages and compared directly as well as with baseline-corrected CBF maps. The study team will determine if a significant difference at different dosages exists.
1 secondary outcome
Change in Blood Glucose (serum or point of care capillary)
Time frame: Baseline (Immediately before drug administration), up to approximately 90 minutes (after drug dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Schmitzberger, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal insulin in people with Healthy, run by Florian Schmitzberger at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Signal response using fMRI after administration of intranasal insulin (time frame: Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.