Multiple SclerosisMS-MIDYNCT03052595
Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance
An observational study of Multiple Sclerosis and Mitochondrial Alteration, run by Slovak Academy of Sciences at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Mitochondrial Alteration
- What is being tested?
- Oral glucose tolerance test, Testing of autonomous nervous system function and Stroop test
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Feb 2017to 31 Mar 2023
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- smoking, pregnancy, lactation, received a course of steroids (intravenous or oral) within 60 days of screening, diabetes, hypertension
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch
Bratislava, 84505
About this study
Official title: Multiple Sclerosis: The Role of Mitochondrial Dysfunction in Insulin Resistance
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Mitochondrial Alteration
- Being tested
- Oral glucose tolerance test, Testing of autonomous nervous system function, Stroop test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load
Testing of autonomous nervous system functionDiagnostic test
Autonomous nervous system function will be assessed using a battery of tests (orthostasis, Valsalva manoeuvre, heart rate variability recording, blood hormone levels, ect.)
Stroop testDiagnostic test
Stroop test will be used to test cognitive function
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Testing of autonomous nervous system function; Diagnostic Test: Stroop test | |
| 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) Receives: Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Testing of autonomous nervous system function; Diagnostic Test: Stroop test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity indices calculated from plasma glucose and insulin concentrations during oral glucose tolerance test
Measured: 2017-2019
Secondary outcomes (1)
Expanded Disability Status Scale (EDSS)
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.
Measured: 2017-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Feb 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Adela Penesova, MD, PhD, Slovak Academy of Sciences
- Investigators
- Viera Sevcikova, Ing, Study chair, Biomedical Research Center of Slovak Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052595
- Sponsor's protocol ID
- APVV 15-0228
- Acronym
- MS-MIDY
- Status last verified
- Apr 2023
- First submitted
- 10 Feb 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kollar B, Penesova A, Klepochova R, Siarnik P, Vlcek M, Krumpolec P, Mosna L, Imrich R, Turcani P, Radikova Z, Krssak M. Skeletal muscle mitochondrial impairment in patients with newly diagnosed multiple sclerosis revealed by (1)H/(3)(1)P magnetic resonance spectroscopy. Sci Rep. 2026 Jun 11. doi: 10.1038/s41598-026-54705-8. Online ahead of print.
PubMed 42277226Imrich R, Vlcek M, Penesova A, Radikova Z, Havranova A, Sivakova M, Siarnik P, Kollar B, Sokolov T, Turcani P, Heckova E, Hangel G, Strasser B, Bogner W. Cardiac autonomic function in patients with early multiple sclerosis. Clin Auton Res. 2021 Aug;31(4):553-562. doi: 10.1007/s10286-021-00790-w. Epub 2021 Mar 4.
PubMed 33665745Radikova Z, Penesova A, Vlcek M, Havranova A, Sivakova M, Siarnik P, Zitnanova I, Imrich R, Turcani P, Kollar B. Lipoprotein profiling in early multiple sclerosis patients: effect of chronic inflammation? Lipids Health Dis. 2020 Mar 17;19(1):49. doi: 10.1186/s12944-020-01221-x.
PubMed 32178676
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis: The Role of Mitochondrial Dysfunction in Insulin Resistance
- ClinicalTrials.gov ID
- NCT03052595
- Acronym / sponsor ID
- MS-MIDY / APVV 15-0228
- Conditions
- Multiple Sclerosis, Mitochondrial Alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- Comenius University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Feb 2017 (actual)
- 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.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SM | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Testing of autonomous nervous system function, Diagnostic Test: Stroop testPatients 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) |
| Control | – | Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Testing of autonomous nervous system function, Diagnostic Test: Stroop testAge, 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- smoking, pregnancy, lactation, received a course of steroids (intravenous or oral) within 60 days of screening, diabetes, hypertension
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 |
|---|---|---|
| Oral glucose tolerance testOral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load | Diagnostic test | Control, SM |
| Testing of autonomous nervous system functionAutonomous nervous system function will be assessed using a battery of tests (orthostasis, Valsalva manoeuvre, heart rate variability recording, blood hormone levels, ect.) | Diagnostic test | Control, SM |
| Stroop testStroop test will be used to test cognitive function | Diagnostic test | Control, SM |
Primary outcome
Insulin sensitivity
Time frame: 2017-2019
Insulin sensitivity indices calculated from plasma glucose and insulin concentrations during oral glucose tolerance test
1 secondary outcome
Expanded Disability Status Scale (EDSS)
Time frame: 2017-2020
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 12 Apr 2023.
- Derived from this study: PubMed 42277226Kollar B, Penesova A, Klepochova R, Siarnik P, Vlcek M, Krumpolec P, Mosna L, Imrich R, Turcani P, Radikova Z, Krssak M. Skeletal muscle mitochondrial impairment in patients with newly diagnosed multiple sclerosis revealed by (1)H/(3)(1)P magnetic resonance spectroscopy. Sci Rep. 2026 Jun 11. doi: 10.1038/s41598-026-54705-8. Online ahead of print.
- Derived from this study: PubMed 33665745Imrich R, Vlcek M, Penesova A, Radikova Z, Havranova A, Sivakova M, Siarnik P, Kollar B, Sokolov T, Turcani P, Heckova E, Hangel G, Strasser B, Bogner W. Cardiac autonomic function in patients with early multiple sclerosis. Clin Auton Res. 2021 Aug;31(4):553-562. doi: 10.1007/s10286-021-00790-w. Epub 2021 Mar 4.
- Derived from this study: PubMed 32178676Radikova Z, Penesova A, Vlcek M, Havranova A, Sivakova M, Siarnik P, Zitnanova I, Imrich R, Turcani P, Kollar B. Lipoprotein profiling in early multiple sclerosis patients: effect of chronic inflammation? Lipids Health Dis. 2020 Mar 17;19(1):49. doi: 10.1186/s12944-020-01221-x.
- Individual participant dataSharing planned: Undecided
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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.
Viera Sevcikova, Ing study chair
Biomedical Research Center of Slovak Academy of Sciences
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 Multiple Sclerosis and Mitochondrial Alteration, run by Slovak Academy of Sciences at 1 site in Slovakia.
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 4 inclusion and 1 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 12 Apr 2023. 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 Slovakia. 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?
Insulin sensitivity (time frame: 2017-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052595, which also lists 3 linked publications.
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 12 Apr 2023.