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

NCT ID: NCT06144255

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-17
• Study Completion Date: 2024-02-22

Brief 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. 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intranasal insulin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

HUMULIN R U-500

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florian Schmitzberger

OTHER

Sponsor Role: lead

Responsible Party

Florian Schmitzberger

Instructor in Emergency Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Florian Schmitzberger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00230748

Identifier Type: -

Identifier Source: org_study_id