Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance
NCT ID: NCT03052595
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2017-02-01
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
Oral glucose tolerance test
Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load
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.)
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)
Oral glucose tolerance test
Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load
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.)
Stroop test
Stroop test will be used to test cognitive function
Interventions
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Oral glucose tolerance test
Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load
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.)
Stroop test
Stroop test will be used to test cognitive function
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Comenius University
OTHER
Slovak Academy of Sciences
OTHER_GOV
Responsible Party
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Adela Penesova, MD, PhD
Responsible Clinical Investigator
Principal Investigators
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Viera Sevcikova, Ing
Role: STUDY_CHAIR
Biomedical Research Center of Slovak Academy of Sciences
Locations
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Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch
Bratislava, , Slovakia
Countries
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References
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Imrich 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.
Radikova 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.
Other Identifiers
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APVV 15-0228
Identifier Type: -
Identifier Source: org_study_id
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