Status:
COMPLETED
Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI)
Lead Sponsor:
Florian Schmitzberger
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06144255
Start Date
November 17 2023
End Date
February 22 2024
Last Update
March 21 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109