Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI)

March 19, 2024 updated by: Florian Schmitzberger

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal insulin and placebo
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.
Drug: Intranasal insulin

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.

Other Names:
  • HUMULIN R U-500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline (Immediately before drug administration), up to approximately 90 minutes (after drug dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florian Schmitzberger

Investigators

  • Principal Investigator: Florian Schmitzberger, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Actual)

February 22, 2024

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00230748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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