Suspended

Intranasal Insulin: A Novel Treatment for Gulf War Multisymptom Illness

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What is being tested

Intranasal Insulin

+ Intranasal Insulin

+ Placebos

Drug
Who is being recruted

From 40 to 89 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2014
See protocol details

Summary

Principal SponsorBronx Veterans Medical Research Foundation, Inc
Study ContactAllison J Markiewicz, MSWMore contacts
Last updated: October 6, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

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.

Principal SponsorBronx Veterans Medical Research Foundation, Inc
Study ContactAllison J Markiewicz, MSWMore contacts
Last updated: October 6, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

114 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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

8 exclusion criteria prevent from participating
Veteran has a history of hypoglycemia

Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or type I bipolar disorder

Veteran has an irregular nasal cavity (i.e. nasal polyps etc.) or is using nasal sprays on a regular basis

Veteran has diabetes, a major medical or neurological disorder or moderate-severe traumatic brain injury

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
10 IU BID Intranasal Insulin

Group II

Experimental
20 IU BID Intranasal Insulin

Group III

Experimental
Saline nasal solution used as placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

VA Boston Healthcare System

Boston, United StatesOpen VA Boston Healthcare System in Google Maps
Recruiting

James J. Peters VA Medical Center

The Bronx, United States
Suspended2 Study Centers