Chronic Multisymptom Illness in Gulf War VeteransPhase 2NCT01802944
Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness
A Phase 2 study testing Intranasal Insulin in people with Chronic Multisymptom Illness in Gulf War Veterans, run by Bronx Veterans Medical Research Foundation, Inc at 2 sites in United States.
Trial 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 pain, headaches, gastrointestinal complaints, and mood and sleep problems. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Chronic Multisymptom Illness in Gulf War Veterans
- What is being tested?
- Intranasal Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
VA Boston Healthcare System
Boston, Massachusetts, 02130
Maxine Krengel, PhD, 617-232-9500, Maxine.Krengel@va.gov
Maxine Krengel, PhD
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Julia A Golier, MD, 718-584-9000 ext. 5196, Julia.Golier@va.gov
Julia A Golier, MD
About this study
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 pain, headaches, gastrointestinal complaints, and mood and sleep problems. Despite the passage of time, the symptom complex persists for many veterans. Indeed, it is estimated that at least 25 percent of GWV (nearly 170,000 veterans) have a persistent form of chronic multisymptom illness (CMI). GW deployed veterans are also developing significantly more chronic diseases such as diabetes, hypertension, arthritis, and coronary heart disease than their non-deployed veteran peers putting these individuals at risk for accelerated aging-related diseases of the peripheral and central nervous system (CNS). Recent studies have shown a slowing of response speed that affects mental flexibility across multiple cognitive domains (memory, attention, visuospatial functions) especially on tests that were timed and computerized and where small differences in cognitive reaction times could be measured. Recent studies also have suggested that the response inhibition deficits shown in GWV may reflect executive system dysfunction as reflected by slower motor responses across multiple cognitive domains.
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.
Read more
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.
- Being tested
- Intranasal Insulin, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal InsulinDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| 10 IU BID | Experimental | 10 IU BID Intranasal Insulin Receives: Drug: Intranasal Insulin |
| 20 IU BID | Experimental | 20 IU BID Intranasal Insulin Receives: Drug: Intranasal Insulin |
| PLACEBOS | Experimental | Saline nasal solution used as placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory Functioning
To assess the efficacy of two different doses (10 IU BID and 20 IU BID) of daily intranasal insulin for eight weeks on memory functioning in Gulf War Veterans with Chronic Multisymptom Illness. The primary clinical outcome measure will be a change in the performance on the delayed verbal memory score on a list learning task (California Verbal Learning Test (CVLT). To determine the sustainability of change in cognitive status, the response from treatment endpoint (end of 8-week treatment period) to one month follow-up (post end of 8-week treatment period) will also be assessed for the primary outcome measure.
Measured: Eight weeks
Attention Functioning
To assess the efficacy of two different doses (10 IU BID and 20 IU BID) of daily intranasal insulin for eight weeks on attention functioning in Gulf War Veterans with Chronic Multisymptom Illness. The primary clinical outcome measure will be a change in performance on a selective attention task (Stroop Color-Word Interference Task) from treatment baseline to endpoint. To determine the sustainability of change in cognitive status, the response from treatment endpoint (end of 8-week treatment period) to one month follow-up (post end of 8-week treatment period) will also be assessed for the outcome measure.
Measured: Eight Weeks
Secondary outcomes (2)
Physical Health
An outcome measure will be the changes in physical health over the course of active treatment. The primary measure of physical health will be the Physical Components Score (PCS) from the Standard Form 12-veteran version (SF-12V). The clinical outcome measure will be the change in PCS score from treatment baseline to endpoint. To determine the sustainability of change in PCS scores, the response from treatment endpoint to one month follow-up will also be assessed.
Measured: Eight weeks
Mood
An outcome measure will be the changes in mood over the course of active treatment. The primary measure of mood will be obtained from the Profile of Mood States (POMS) vigor scale. The clinical outcome measure will be the change in POMS scores from treatment baseline to endpoint. To determine the sustainability of change in POMS scores, the response from treatment endpoint to one month follow-up will also be assessed.
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Multisymptom Illness in Gulf War VeteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bronx Veterans Medical Research Foundation, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- VA Boston Healthcare System, Boston University
- Responsible party
- Sponsor
- Investigators
- Julia Golier, MD, Principal investigator, Chief of Psychiatry Bronx VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802944
- Sponsor's protocol ID
- GW110054
- Status last verified
- Oct 2017
- First submitted
- 19 Feb 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness
- ClinicalTrials.gov ID
- NCT01802944
- Acronym / sponsor ID
- GW110054
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Bronx Veterans Medical Research Foundation, IncUniversity, hospital or other
- Collaborators
- VA Boston Healthcare System, Boston University
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 pain, headaches, gastrointestinal complaints, and mood and sleep problems. Despite the passage of time, the symptom complex persists for many veterans. Indeed, it is estimated that at least 25 percent of GWV (nearly 170,000 veterans) have a persistent form of chronic multisymptom illness (CMI). GW deployed veterans are also developing significantly more chronic diseases such as diabetes, hypertension, arthritis, and coronary heart disease than their non-deployed veteran peers putting these individuals at risk for accelerated aging-related diseases of the peripheral and central nervous system (CNS). Recent studies have shown a slowing of response speed that affects mental flexibility across multiple cognitive domains (memory, attention, visuospatial functions) especially on tests that were timed and computerized and where small differences in cognitive reaction times could be measured. Recent studies also have suggested that the response inhibition deficits shown in GWV may reflect executive system dysfunction as reflected by slower motor responses across multiple cognitive domains.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 IU BID | Experimental | Drug: Intranasal Insulin10 IU BID Intranasal Insulin |
| 20 IU BID | Experimental | Drug: Intranasal Insulin20 IU BID Intranasal Insulin |
| PLACEBOS | Experimental | Drug: PlacebosSaline nasal solution used as placebo |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Insulin | Drug | 10 IU BID, 20 IU BID |
| Placebos | Drug | PLACEBOS |
Primary outcome
Memory Functioning
Time frame: Eight weeks
To assess the efficacy of two different doses (10 IU BID and 20 IU BID) of daily intranasal insulin for eight weeks on memory functioning in Gulf War Veterans with Chronic Multisymptom Illness. The primary clinical outcome measure will be a change in the performance on the delayed verbal memory score on a list learning task (California Verbal Learning Test (CVLT). To determine the sustainability of change in cognitive status, the response from treatment endpoint (end of 8-week treatment period) to one month follow-up (post end of 8-week treatment period) will also be assessed for the primary outcome measure.
Attention Functioning
Time frame: Eight Weeks
To assess the efficacy of two different doses (10 IU BID and 20 IU BID) of daily intranasal insulin for eight weeks on attention functioning in Gulf War Veterans with Chronic Multisymptom Illness. The primary clinical outcome measure will be a change in performance on a selective attention task (Stroop Color-Word Interference Task) from treatment baseline to endpoint. To determine the sustainability of change in cognitive status, the response from treatment endpoint (end of 8-week treatment period) to one month follow-up (post end of 8-week treatment period) will also be assessed for the outcome measure.
2 secondary outcomes
Physical Health
Time frame: Eight weeks
Mood
Time frame: Eight Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Golier, MD principal investigator
Chief of Psychiatry Bronx VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Insulin in people with Chronic Multisymptom Illness in Gulf War Veterans, run by Bronx Veterans Medical Research Foundation, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison J Markiewicz, MSW ((718) 584-9000 ext. 6567, Allison.Markiewicz@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory Functioning (time frame: Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.