- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01918501
Testing Mitochondria Activity and Blood Lipid Content of Multiple Sclerosis Patients
Background: Multiple sclerosis (MS) is a complex and multifactorial neurological disease characterized by infiltration of immune cells and progressive damage to myelin and axons. Remyelination, the generation of new myelin in the adult nervous system, is an endogenous repair mechanism that restores function of axons. Neurons require considerable energy for their activities, including synaptic neurotransmission, and hence have significant numbers of mitochondria. Unlike other cell types that are able to utilize glycolysis as an alternative energy source, glycolysis in fully differentiated neurons is basically suppressed to maintain their antioxidant status. This property makes neurons highly vulnerable to ATP deficiency, and may be a factor in the susceptibility of neurons to cell death. Mitochondria provide cellular energy by converting oxygen and nutrients into adenosine triphosphate (ATP); and reflect local metabolic needs and via oxidative phosphorylation. Nervous tissues contain about 70% lipids of their dry weight, and around 40% of these lipids are polyunsaturated fatty acids (PUFAs).
Goal: Understanding the relationship between blood composition, mitochondria role and clinical status.
Here, we will examine expression levels of different fatty acids in the blood and monitor mitochondrial transmembrane potential as marker for the mitochondria general function.
Hypothesis: Remyelination efficiency in MS is likely mediated by many factors, besides reducing inflammation. Remyelination may not be achieved correctly /sufficient in MS patients due to nutrition low content causing mitochondrial dysfunction and/or due to fatty acid molecules deficit unable to create a new myelin layer.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayelet Omer-Armon, PHD
- Phone Number: 972-4-6828146
- Email: ayelet.o@ziv.health.gov.il
Study Locations
-
-
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Safed, Israel, 13100
- Recruiting
- Ziv Medical Center
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Contact:
- Ayelet Omer-Armon, PHD
- Phone Number: 972-4-6828146
- Email: ayelet.o@ziv.health.gov.il
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Sub-Investigator:
- Ayelet Omer-Armon, PHD
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Sub-Investigator:
- Saad Abu Saleh, MD
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Sub-Investigator:
- Adi Nov-Sharabi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-60
Exclusion Criteria:
- Other diseases, pathologies, or immune system disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Blood testing
Comparison of nutrition factors in MS patients and healthy volunteers as possibly source for the pathogenesis and for the remyelination process.
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Blood sample will be taken once from 120 volunteers.
The blood will be examine in a blind fashion, including 60 MS patients diagnosed by a neurologist based on clinical and MRI findings.
The control group will include 50 age and gender match healthy volunteers and 10 more patients with unrelated neurological diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of approximately 30 fatty acids in the serum and in erythrocyte samples.
Time Frame: Up to 2 years
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Upon enrollment, a single blood sample of approximately 20 ml will be taken.
Samples of serum and in erythrocyte will be analyzed by gas chromatography mass spectrometry.
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Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitor mitochondrial transmembrane potential as a marker for the mitochondria general function.
Time Frame: Up to 2 years
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Upon enrollment, a single blood sample of approximately 20 ml will be taken.
Mitochondrial transmembrane potential of platelets and lymphocytes will be analyzed by flow cytometry following specific staining.
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Up to 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Develop a simple method for utilizing common flow cytometry to identify MS by examining the response of lymphocytes to myelin antigens.
Time Frame: Up to 2 years
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Upon enrollment, a single blood sample of approximately 20 ml will be taken.
The interaction of antigen and lymphocytes induces a cascade of cellular events.
We will measured responses in myelin antigen treated lymphocytes from all volunteers.
After, we will utilized the fluorescence measurement of fluorescein diacetate and carboxyfluorescein diacetate succinimidyl ester (CFSE).
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Up to 2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0037-13-ZIV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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