Gulf War SyndromeNCT01264471
Mechanisms of Mitochondrial Defects in Gulf War Syndrome
An observational study of Gulf War Syndrome and Mitochondrial Disease, run by Medical Neurogenetics, LLC at 1 site in United States.
Trial summary
The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gulf War Syndrome, Mitochondrial Disease
- What is being tested?
- Skin biopsy and Blood Collection
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gulf War Veterans who have been diagnosed with Gulf War Syndrome
Who may be able to join
- Short-term memory loss or a severe inability to concentrate that affects work, school or other normal activities
- Muscle Pain, myalgias
- Pain without redness or swelling in a number of joints
- Intense or changing patterns of headaches
- Unrefreshing sleep
- After any exertion, weariness that lasts for more than a day
Who cannot join
- Organ failure (e.g. emphysema, cirrhosis, cardiac failure, chronic renal failure)
- Chronic infections (e.g. HIV/AIDS, hepatitis B or C)
- Rheumatic and chronic inflammatory diseases (e.g. systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis.)
- Major neurologic diseases (e.g. multiple sclerosis, neuromuscular diseases, epilepsy or other disease requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
- Diseases requiring systemic treatment (e.g. organ or bone marrow transplantation; systemic chemotherapy; radiation of brain, thorax, abdomen, or pelvis)
- Major endocrine diseases (e.g. hypopituitarism, adrenal insufficiency)
Show all 11Show fewer
- Myocardial infarction, heart failure
- Morbid obesity (body mass index >40)
- Permanent psychiatric exclusions: Lifetime diagnoses of bipolar affective disorders, schizophrenia or any subtype, delusional disorders of any subtype, dementias of any subtype, organic brain disorders, and alcohol or substance abuse within 2 years before onset of the fatiguing illness.
- History of allergic reaction to lidocaine
- History of keloid formation with skin incisions.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the "power plants" of the body. Mitochondria take the food you eat and break the food down into a form of energy that the body can use. The investigators propose that Gulf War Syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. This study will be the first investigation of mitochondrial function in Gulf War Syndrome. The investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify Gulf War Syndrome, and ultimately develop treatment protocols for Gulf War Syndrome.
- Conditions
- Gulf War Syndrome, Mitochondrial Disease
- Being tested
- Skin biopsy, Blood Collection
- Keywords
- Gulf War Syndrome, Gulf War Illness, Mitochondrial defects, Mitochondrial disorders, Persian Gulf Syndrome
- Medical subject headings
- Persian Gulf Syndrome, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
Also called skin sample
A small skin sample will be obtained from the patients arm which is approximately the size of the top of a thumbtack (a small circle no more than a 1/4 inch across)
Blood CollectionProcedure or surgery
Also called phlebotomy, blood draw
Approximately 45ml or 3 tablespoons for blood will be drawn from a vein in the patient's forearm.
| Study group | Role | What they receive |
|---|---|---|
| Gulf War Syndrome patients | Gulf War veterans who have been diagnosed with Gulf War Syndrome. Receives: Procedure: Skin biopsy; Procedure: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize mitochondrial cellular energetics in Gulf War Syndrome patients
After collecting a skin and blood sample, mitochondrial cellular energetics in Gulf War Syndrome patients will be characterized by: 1. high resolution respirometry of intact cells, 2. quantitative analysis of individual mitochondrial proteins, 3. analysis of intact OXPHOS enzyme complexes and supercomplexes, 4. in gel enzyme activity assessment of intact OXPHOS enzyme complexes and supercomplexes, 5. mitochondrial DNA (mtDNA) copy number quantitation to assess for defects in regulation mtDNA replication and 6. cellular coenzyme Q10 quantitation.
Measured: approximately 2 years; once all data has been collected from study participants
Secondary outcomes (1)
Mitochondrial DNA
Assess the mitochondrial DNA (mtDNA) from each patient with Gulf War Syndrome for mtDNA mutations by whole genome sequencing of leukocyte and skin cell mtDNA.
Measured: approximately 2 years; once all data has been collected from study participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startMay 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Neurogenetics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, John M. Shoffner, Medical Neurogenetics, LLC
- Investigators
- John M Shoffner, MD, Principal investigator, Medical Neurogenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264471
- Sponsor's protocol ID
- H09378
- Other IDs
- GW080138
- Status last verified
- Apr 2015
- First submitted
- 17 Dec 2010
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Mitochondrial Defects in Gulf War Syndrome
- ClinicalTrials.gov ID
- NCT01264471
- Acronym / sponsor ID
- H09378
- Conditions
- Gulf War Syndrome, Mitochondrial Disease
- Keywords
- Gulf War Syndrome, Gulf War Illness, Mitochondrial defects, Mitochondrial disorders, Persian Gulf Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical Neurogenetics, LLCUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- May 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Dec 2010 (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.
The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the "power plants" of the body. Mitochondria take the food you eat and break the food down into a form of energy that the body can use. The investigators propose that Gulf War Syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. This study will be the first investigation of mitochondrial function in Gulf War Syndrome. The investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify Gulf War Syndrome, and ultimately develop treatment protocols for Gulf War Syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gulf War Syndrome patients | – | Procedure: Skin biopsy, Procedure: Blood CollectionGulf War veterans who have been diagnosed with Gulf War Syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gulf War Veterans who have been diagnosed with Gulf War Syndrome
Key inclusion criteria (6 listed)
- Short-term memory loss or a severe inability to concentrate that affects work, school or other normal activities
- Muscle Pain, myalgias
- Pain without redness or swelling in a number of joints
- Intense or changing patterns of headaches
- Unrefreshing sleep
Key exclusion criteria (11 listed)
- Organ failure (e.g. emphysema, cirrhosis, cardiac failure, chronic renal failure)
- Chronic infections (e.g. HIV/AIDS, hepatitis B or C)
- Rheumatic and chronic inflammatory diseases (e.g. systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis.)
- Major neurologic diseases (e.g. multiple sclerosis, neuromuscular diseases, epilepsy or other disease requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
- Diseases requiring systemic treatment (e.g. organ or bone marrow transplantation; systemic chemotherapy; radiation of brain, thorax, abdomen, or pelvis)
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 |
|---|---|---|
| Skin biopsyAlso: skin sampleA small skin sample will be obtained from the patients arm which is approximately the size of the top of a thumbtack (a small circle no more than a 1/4 inch across) | Procedure or surgery | Gulf War Syndrome patients |
| Blood CollectionAlso: phlebotomy, blood drawApproximately 45ml or 3 tablespoons for blood will be drawn from a vein in the patient's forearm. | Procedure or surgery | Gulf War Syndrome patients |
Primary outcome
Characterize mitochondrial cellular energetics in Gulf War Syndrome patients
Time frame: approximately 2 years; once all data has been collected from study participants
After collecting a skin and blood sample, mitochondrial cellular energetics in Gulf War Syndrome patients will be characterized by: 1. high resolution respirometry of intact cells, 2. quantitative analysis of individual mitochondrial proteins, 3. analysis of intact OXPHOS enzyme complexes and supercomplexes, 4. in gel enzyme activity assessment of intact OXPHOS enzyme complexes and supercomplexes, 5. mitochondrial DNA (mtDNA) copy number quantitation to assess for defects in regulation mtDNA replication and 6. cellular coenzyme Q10 quantitation.
1 secondary outcome
Mitochondrial DNA
Time frame: approximately 2 years; once all data has been collected from study participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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.
John M Shoffner, MD principal investigator
Medical Neurogenetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gulf War Syndrome and Mitochondrial Disease, run by Medical Neurogenetics, LLC at 1 site 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize mitochondrial cellular energetics in Gulf War Syndrome patients (time frame: approximately 2 years; once all data has been collected from study participants). 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 13 Apr 2015.