Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness
NCT ID: NCT01802944
Last Updated: 2017-10-06
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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UNKNOWN
PHASE2
114 participants
INTERVENTIONAL
2014-04-30
2017-12-31
Brief Summary
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To date, there are no treatments that have been shown to improve the health or cognitive difficulties of GW veterans; thus there is an urgent need to establish effective, safe, and tolerable treatments for GW CMI. Previous studies in other cognitive disorders have found that intranasal insulin improves memory, attention, and mood, reduces neuroinflammation, and modulates cortisol levels; it has also been identified as a treatment that has the capacity to alter many of the leading problems of GW CMI.
During this study there are 2 treatment groups and a placebo group that will last for 8 weeks. The treatment groups will self-administer their designated dosage of insulin through a nasal pump twice a day, while the placebo group will administer saline through a nasal pump twice a day. These doses have been shown to be effective and safe. The primary outcome measure will assess improvements in verbal delayed memory using a specific list learning task and on a measure of selective attention. The study will assess improvements in overall physical health and mood by asking the participants to complete self report questionnaires. Neuroendocrine measures will also be obtained in order to evaluate changes in glucose, insulin, and cortisol levels and examine their impact on GW CMI.
Intranasal insulin has shown great promise in improving memory, attention, and mood in both older adults with cognitive impairment as well as normal subjects. Thus, this proposal could prove intranasal insulin to be an effective, safe, and affordable therapy for these ailing veterans.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 IU BID
10 IU BID Intranasal Insulin
Intranasal Insulin
20 IU BID
20 IU BID Intranasal Insulin
Intranasal Insulin
PLACEBOS
Saline nasal solution used as placebo
Placebos
Interventions
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Intranasal Insulin
Placebos
Eligibility Criteria
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Inclusion Criteria
* Veteran meets criteria for chronic multisymptom illness based Kansas Gulf War Study (Steele, 2000) criteria and must meet criteria in the cognitive symptom domain.
Exclusion Criteria
* Veteran has diabetes, a major medical or neurological disorder or moderate-severe traumatic brain injury.
* Veteran has a history of hypoglycemia.
* Veteran is taking oral or nasal corticosteroids, insulin or oral hypoglycemic agents.
* Veteran has an irregular nasal cavity (i.e. nasal polyps etc.) or is using nasal sprays on a regular basis.
* Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or type I bipolar disorder.
* Veteran is at high risk from a mental perspective as evidence by having been psychiatrically hospitalized or attempted suicide within the previous 2 years or has current active suicidal ideation.
* Veteran is pregnant or breastfeeding or plans to become pregnant within the year.
40 Years
89 Years
ALL
No
Sponsors
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VA Boston Healthcare System
FED
Boston University
OTHER
Bronx Veterans Medical Research Foundation, Inc
OTHER
Responsible Party
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Principal Investigators
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Julia Golier, MD
Role: PRINCIPAL_INVESTIGATOR
Chief of Psychiatry Bronx VA Medical Center
Locations
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VA Boston Healthcare System
Boston, Massachusetts, United States
James J. Peters VA Medical Center
The Bronx, New York, 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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GW110054
Identifier Type: -
Identifier Source: org_study_id