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fMRI Study of Effects of Nasal Insulin on Memory

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Completed
CT.gov ID
NCT02758691
Collaborator
(none)
45
Enrollment
2
Arms
17.3
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intranasal Insulin
  • Drug: Intranasal Saline
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Examining the Neural Correlates of Memory in Response to Intranasal Insulin Through fMRI & Device Testing
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
May 10, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intranasal Insulin

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.

Drug: Intranasal Insulin
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.
Other Names:
  • Humulin® R U-100

    		•
    Placebo Comparator: Saline Placebo

    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.

    Drug: Intranasal Saline
    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.
    Other Names:
  • Sterile Water

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Memory Recall Performance during functional Magnetic Resonance Imaging task [1 day]

      Recall performance will be measured based off a forced recall memory task. Participants will be asked to categorizes images as indoor or outdoor during an encoding task and then show a series of images and asked to indicated if the pictures is 'old' or 'new' in a recall task. The score will be calculated as a percentage of images correctly identified as 'old.'

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Virginia Polytechnic Institute and State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rosalyn Moran, Assistant Professor, Virginia Polytechnic Institute and State University
    ClinicalTrials.gov Identifier:
    NCT02758691
    Other Study ID Numbers:
    • VT15-462
    First Posted:
    May 2, 2016
    Last Update Posted:
    Oct 26, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by Rosalyn Moran, Assistant Professor, Virginia Polytechnic Institute and State University
    memory
    insulin
    Additional relevant MeSH terms:
    Insulin
    Insulin, Globin Zinc

    Study Results

    No Results Posted as of Oct 26, 2018