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Trial record 1 of 1 for:    NCT 03052595
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Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance (MS-MIDY)

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ClinicalTrials.gov Identifier: NCT03052595
Recruitment Status : Unknown
Verified December 2018 by Adela Penesova, MD, PhD, Slovak Academy of Sciences.
Recruitment status was:  Recruiting
First Posted : February 14, 2017
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Comenius University
Information provided by (Responsible Party):
Adela Penesova, MD, PhD, Slovak Academy of Sciences

Study Description
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Brief Summary:
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS) and is one of the most common neurological diseases, often leading to disability of the patients. The MS pathogenesis includes vascular and inflammatory components, however recently also the role of mitochondrial dysfunction being a hot topic in neurodegeneration.

Condition or disease Intervention/treatment
Multiple Sclerosis Mitochondrial Alteration Diagnostic Test: Oral glucose tolerance test Diagnostic Test: Testing of autonomous nervous system function Diagnostic Test: Stroop test

Detailed Description:
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS) and is one of the most common neurological diseases, often leading to disability of the patients. The MS pathogenesis includes vascular and inflammatory components, however recently also the role of mitochondrial dysfunction being a hot topic in neurodegeneration. Current project is based on previous project results, where the investigators of this project found signs of insulin resistance (IR) with hyperinsulinemia in patients with MS, which seem not to be related to chronic inflammation or low physical activity. Therefore aim of the present project is to elucidate impact of mitochondrial dysfunction in the pathogenesis of impaired insulin action and its role in the neurodegenerative process. To test the hypothesis, mitochondrial function, endothelial function, changes in membrane proteins and function of autonomic nervous system will be assessed. Those parameters will be measured non-invasively and in samples of blood, cerebrospinal fluid and skeletal muscle. MS patients will be examined at the time of diagnosis and after 12 months of treatment; healthy subjects will be used as controls. Elucidation of insulin resistance cause and the role of mitochondrial dysfunction in pathogenesis of disease is expected. Potential outcome of the project could be the answer, if pharmacological or non-pharmacological intervention might lead to improvement of mitochondrial function and therefore represent a new approach to prevent MS progression.
Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multiple Sclerosis: The Role of Mitochondrial Dysfunction in Insulin Resistance
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
SM
Patients with newly diagnosed multiple sclerosis undergo Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load Patients undergo testing of autonomous nervous system function and testing of cognitive function (Stroop test)
 Diagnostic Test: Oral glucose tolerance test
Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load

Diagnostic Test: Testing of autonomous nervous system function
Autonomous nervous system function will be assessed using a battery of tests (orthostasis, Valsalva manoeuvre, heart rate variability recording, blood hormone levels, ect.)

Diagnostic Test: Stroop test
Stroop test will be used to test cognitive function
Control
Age, sex, Body Mass Index (BMI) matched healthy subjects undergo Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load Healthy controls undergo testing of autonomous nervous system function and testing of cognitive function (Stroop test)
 Diagnostic Test: Oral glucose tolerance test
Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load

Diagnostic Test: Testing of autonomous nervous system function
Autonomous nervous system function will be assessed using a battery of tests (orthostasis, Valsalva manoeuvre, heart rate variability recording, blood hormone levels, ect.)

Diagnostic Test: Stroop test
Stroop test will be used to test cognitive function


Outcome Measures
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Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 2017-2019 ]
    Insulin sensitivity indices calculated from plasma glucose and insulin concentrations during oral glucose tolerance test


Secondary Outcome Measures :
  1. Expanded Disability Status Scale (EDSS) [ Time Frame: 2017-2020 ]
    Expanded Disability Status Scale (EDSS) was developed for rating overall disability in MS. Patients are graded on the basis of presenting symptoms in eight different functional systems (FS), including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, mental, and other functions. Scoring of the EDSS uses a 0 to 10, 20-step scale, with 0 equal to normal neurological function, 6.0 requires an assistive device for walking and 10.0 equal to death due to MS. The final score is based on grades obtained in the FS assessment.


Biospecimen Retention:   Samples With DNA
MicroRNA, DNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with newly diagnosed MS will be examined twice: immediately after the diagnosis confirmation and after at least 12 months of MS treatment
Criteria

Inclusion Criteria for MS patients:

  • Age: 18-45 years
  • Recent diagnosis of MS based on McDonald criteria
  • Functional disability defined by the EDDS in the range of 2 to 6
  • Patient demonstrates ability to successfully perform physical therapy exercises and procedures independently or with assistance of a caregiver

Exclusion Criteria:

  • smoking, pregnancy, lactation, received a course of steroids (intravenous or oral) within 60 days of screening, diabetes, hypertension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052595


Contacts
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Contact: Adela Penesova, MD, PhD +421 2 3229 5245 adela.penesova@savba.sk
Contact: Richard Imrich, MD, DsC +421 2 3229 5243 richard.imrich@savba.sk

Locations
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Slovakia
Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch Recruiting
Bratislava, Slovakia, 84505
Contact: Adela Penesova, MD. PhD    00421 2 322952245    adela.penesova@savba.sk   
Contact: Miroslav Vlcek, MD. PhD    00421 2 322952244    miroslav.vlcek@savba.sk   
Sub-Investigator: Richard Imrich, MD. PhD         
Sub-Investigator: Zuzana Dean, MD         
Sponsors and Collaborators
Slovak Academy of Sciences
Comenius University
Investigators
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Study Chair: Viera Sevcikova, Ing Biomedical Research Center of Slovak Academy of Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Adela Penesova, MD, PhD, Responsible Clinical Investigator, Slovak Academy of Sciences
ClinicalTrials.gov Identifier: NCT03052595    
Other Study ID Numbers: APVV 15-0228
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases