Effect of Physiologic Insulin Administration on Insulin Sensitivity and Cognition
NCT ID: NCT07265323
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8 participants
INTERVENTIONAL
2025-12-31
2027-05-31
Brief Summary
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The main questions it aims to answer are:
Does the intervention improve insulin sensitivity (how the body uses glucose)?
Does the intervention improve cognition, measured by the Montreal Cognitive Assessment (MoCA) and the Revised Memory and Behavior Problems Checklist (RMBPC)?
What changes occur in brain glucose uptake (FDG-PET)?
Participants will:
Receive the intervention once a week for 6 months, with each session lasting up to 2 hours
Complete cognitive assessments. Adverse events will be assessed throughout the study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Physiologic Insulin
Insulin infusion at five-minute intervals over approximately two hours weekly for six months. Initially infusion will be weekly and then frequency will reduce based on participants' response.
Physiological Insulin Intervention
Insulin infusion every five minutes over approximately two hours for six months. Initially infusion will be weekly and then frequency will reduce based on participants' response.
Interventions
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Physiological Insulin Intervention
Insulin infusion every five minutes over approximately two hours for six months. Initially infusion will be weekly and then frequency will reduce based on participants' response.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* An infant, child, or teenager
* A pregnant woman
* A prisoner
* Having any condition that impedes testing of the study hypothesis or are otherwise deemed to be unsuitable (determined by the investigative team).
18 Years
ALL
No
Sponsors
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Pennington Biomedical Research Center
OTHER
Responsible Party
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Tim Gilbert
Principal Investigator
Principal Investigators
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Tim Gilbert, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PBRC Foundation funds
Identifier Type: OTHER
Identifier Source: secondary_id
2025-019-PBRC
Identifier Type: -
Identifier Source: org_study_id
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