Overview

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

Status:
Completed
Trial end date:
2024-02-22
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Florian Schmitzberger
Treatments:
Insulin
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