Recruiting
Phase 2

Intranasal Insulin

Sponsor:

Bronx Veterans Medical Research Foundation, Inc

Code:

NCT01802944

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Intranasal Insulin

Placebos

Study Details

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 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.

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Study ID

NCT01802944

Start date

Apr, 2014

Status verified date

Oct, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 10 IU BID

10 IU BID Intranasal Insulin

experimental: 20 IU BID

20 IU BID Intranasal Insulin

experimental: PLACEBOS

Saline nasal solution used as placebo

Interventions

Intranasal Insulin

Placebos

Primary outcome measure

  • Memory Functioning [ Time Frame: Eight weeks ]
  • Attention Functioning [ Time Frame: Eight Weeks ]

Central Contacts and Locations

Central contacts

Locations

VA Boston Healthcare System

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Principal Investigator:

Maxine Krengel, PhD

James J. Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Principal Investigator:

Julia A Golier, MD

More Information

Sponsor

Bronx Veterans Medical Research Foundation, Inc

Last update posted

Oct 6, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bronx Veterans Medical Research Foundation, Inc on 2017-10-06.