Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness
NCT01802944, Phase 2, Unknown, Bronx Veterans Medical Research Foundation, Inc
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness | ClinicalTrials.gov |
| NCT number | NCT01802944 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 114 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Bronx Veterans Medical Research Foundation, Inc | ClinicalTrials.gov |
| Conditions | Chronic Multisymptom Illness in Gulf War Veterans | ClinicalTrials.gov |
| Interventions | Intranasal Insulin, Placebos | ClinicalTrials.gov |
| First posted | 2013-03-04 | ClinicalTrials.gov |
| Last updated | 2017-10-06 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Memory Functioning | 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. | ClinicalTrials.gov |
| Primary | Attention Functioning | 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. | ClinicalTrials.gov |
| Secondary | Physical Health | Eight weeks | 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. | ClinicalTrials.gov |
| Secondary | Mood | Eight Weeks | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)