Testing Mitochondria Activity and Blood Lipid Content of Multiple Sclerosis Patients

NCT01918501 | Unknown

• 1 other identifier: 0037-13-ZIV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; Remyelination; Mitochondria; fatty acids

Outcome Measures

Primary Outcomes (1)

• Levels of approximately 30 fatty acids in the serum and in erythrocyte samples.

  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.

  Up to 2 years

Secondary Outcomes (1)

• Monitor mitochondrial transmembrane potential as a marker for the mitochondria general function.

  Up to 2 years

Other Outcomes (1)

• Develop a simple method for utilizing common flow cytometry to identify MS by examining the response of lymphocytes to myelin antigens.

  Up to 2 years

Study Arms (1)

Blood testing

EXPERIMENTAL

Comparison of nutrition factors in MS patients and healthy volunteers as possibly source for the pathogenesis and for the remyelination process.

Procedure: Blood testing

Interventions

Blood testing PROCEDURE

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

Blood testing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60

You may not qualify if:

• Other diseases, pathologies, or immune system disorders.

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

ZIV Medical Center

Safed, 13100, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• RADI SHAHIEN, MD

  Ziv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayelet Omer-Armon, PHD

CONTACT

972-4-6828146; ayelet.o@ziv.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: August 7, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 3, 2013

Record last verified: 2013-08

Locations

IL (1)