Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance (MS-MIDY)

Slovak Academy of Sciences

Status: Completed

Conditions: Mitochondrial Alteration; Multiple Sclerosis

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

Study type: Observational

Funder types: Other

Identifiers

NCT03052595

APVV 15-0228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

70 participants in 2 patient groups

SM

Description:

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)

Treatment:

Diagnostic Test: Stroop test

Diagnostic Test: Oral glucose tolerance test

Diagnostic Test: Testing of autonomous nervous system function

Control

Description:

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)

Treatment:

Diagnostic Test: Stroop test

Diagnostic Test: Oral glucose tolerance test

Diagnostic Test: Testing of autonomous nervous system function