Status:
UNKNOWN
Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness
Lead Sponsor:
Bronx Veterans Medical Research Foundation, Inc
Collaborating Sponsors:
VA Boston Healthcare System
Boston University
Conditions:
Chronic Multisymptom Illness in Gulf War Veterans
Eligibility:
All Genders
40-89 years
Phase:
PHASE2
Brief Summary
Following their deployment to the 1991 Gulf War, many veterans (GWV) reported a constellation of unexplained health symptoms; common among them were attention and memory difficulties, fatigue, joint p...
Eligibility Criteria
Inclusion
- Subject is a veteran of the 1991 Gulf War.
- 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
- Veteran lacks the capacity to provide consent.
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01802944
Start Date
April 1 2014
End Date
December 1 2017
Last Update
October 6 2017
Active Locations (2)
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1
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
2
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468