Overview

This trial is active, not recruiting.

Conditions human memory, intranasal insulin
Treatments intranasal insulin, intranasal saline
Phase phase 1
Sponsor Virginia Polytechnic Institute and State University
Start date December 2015
End date April 2016
Trial size 45 participants
Trial identifier NCT02758691, VT15-462

Summary

Recent research has suggested insulin may be involved in how human's form and recall memories. This study is designed to look at how nasal insulin is used in the brain. Specifically, how insulin alters the various connections within brain regions that occur while adults perform simple attention and memory tasks. This study is divided into two parts: blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The blood draw procedure is designed to look at the effects of intranasal insulin using a Precision Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those asked to participate will receiving a low-dose saline solution and low-dose of insulin through a nasal spray followed by a blood draw session to measure your blood glucose and insulin levels over a 90 minute period.

Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI). During the scan, participants will complete a series of memory tasks reflected on a computer screen. The trial will be randomized and double-blinded.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
Healthy participants will self-administer 20 IU of Humulin® R U-100 with the Precision Olfactory Delivery (POD) delivery device and complete a memory task in an fMRI (functional Magnetic Resonance Imaging) scanner.
intranasal insulin Humulin® R U-100
All participants in the devise testing portion of the study will self-administer a 20 IU dose of intranasal insulin. Half of the participants in the function Magnetic Resonance Imaging portion of the study will also self-administer a 20 IU dose of intranasal insulin.
(Placebo Comparator)
Healthy participants will self-administer a saline solution with the Precision Olfactory Delivery (POD) delivery device and complete a memory task in an fMRI (functional Magnetic Resonance Imaging) scanner.
intranasal saline Sterile Water
All participants in the devise testing portion of the study will self-administer a 20 mL dose of intranasal saline. Half of the participants in the function Magnetic Resonance Imaging portion of the study will also self-administer a 20 mL dose of intranasal saline.

Primary Outcomes

Measure
Change in Memory Recall Performance during functional Magnetic Resonance Imaging task
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - healthy adults over the age of 18 Exclusion Criteria: - any existing health conditions: including diabetes, history of alcoholism or drug dependence - contraindications to Magnetic Resonance Imaging (MRI): any non-titanium metal in the head or body

Additional Information

Official title Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University.