Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance

NCT03052595 | Completed

• 1 other identifier: APVV 15-0228
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Mitochondrial Alteration

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Insulin sensitivity indices calculated from plasma glucose and insulin concentrations during oral glucose tolerance test

  2017-2019

Secondary Outcomes (1)

• Expanded Disability Status Scale (EDSS)

  2017-2020

Study Arms (2)

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; 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)

Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Testing of autonomous nervous system function; Diagnostic Test: Stroop test

Interventions

Oral glucose tolerance test DIAGNOSTIC_TEST

Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load

Control; SM

Testing of autonomous nervous system function DIAGNOSTIC_TEST

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

Control; SM

Stroop test DIAGNOSTIC_TEST

Stroop test will be used to test cognitive function

Control; SM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• smoking, pregnancy, lactation, received a course of steroids (intravenous or oral) within 60 days of screening, diabetes, hypertension

Sponsors & Collaborators

• Slovak Academy of Sciences: lead
• Comenius University: collaborator

Study Sites (1)

Biomedical Center, Slovak Academy of Sciences, Institute of clinical and translational reasearch

Bratislava, 84505, Slovakia

Location

Related Publications (2)

• 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.

  PMID: 33665745 DERIVED

• 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.

  PMID: 32178676 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

MicroRNA, DNA

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Glucose Tolerance Test

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)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Viera Sevcikova, Ing

  Biomedical Research Center of Slovak Academy of Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Clinical Investigator

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: February 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

SL (1)