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

NCT06144255 | Completed Phase 1 FDA Drug

• 1 other identifier: HUM00230748
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Healthy Participants; Intranasal Insulin; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline (Immediately before drug administration), up to approximately 90 minutes (after drug dose)

Study Arms (1)

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.

Drug: Intranasal insulin

Interventions

Intranasal insulin 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.

Also known as: HUMULIN R U-500

Intranasal insulin and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florian Schmitzberger: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Florian Schmitzberger, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor in Emergency Medicine

Model Details: Each volunteer will have 3 study visits, receiving a different study dose at each visit in randomized order as spelled out in the protocol.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: November 17, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)