Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS. MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere.
Product Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere
Pharmaceutical Form: Solution for injection in pre-fi
Sponsors
Lekárska fakulta UK Bratislava
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participant must freely agree to participate in this trial and sign the informed consent by hand prior to performing any procedure in this study. • A man or woman aged 18 to 60 years (inclusive) at the time of the first study visit. • Able to understand the requirements and follow the procedures of this study. • patients with a confirmed diagnosis of multiple sclerosis, with a worse prognosis due to higher disease activity • EDSS =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: main • diabetes mellitus on oral antidiabetics or insulin • other serious chronic diseases • oncological diseases • long-term use of medicines such as. glucocorticoids, antidepressants • pregnancy • breastfeeding • drug use or alcohol abuse • the presence of metal components in the body • Known hypersensitivity to the test product, excipients, or hypersensitivity to a similar structure. other • Participation in another clinical study during the last 3 months before enrollment or concurrent participation in other clinical studies • Previous treatment enrollment during this study • Close connection with the principal examiner (eg a close relative) or the examiner or workplace staff. • The participant is an employee of the client • Criteria that, in the examiner's opinion, exclude participation for scientific or safety reasons of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Annualized change in brain volume and gray matter volume • Serum neurofilament L level;Secondary Objective: • Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2 • Symbol Digit Modalities test (SDMT) and Stroop test scores according to normal workplace practice;Primary end point(s): To determine the effect of GLP-1 receptor agonist on chronic axonal damage and neurodegeneration in patients with MS • Annualized change in brain volume and gray matter volume • Serum neurofilament L level;Timepoint(s) of evaluation of this end point: end of trial participation / month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the effect of GLP-1 receptor agonist on insulin sensitivity in patients with MS • Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2 HOMA-IR = (10 x G0) / 22.5 HOMA2 (http://www.dtu.ox.ac.uk/homacalculator/) To determine the effect of GLP-1 receptor agonist on cognitive functions in patients with SM • Score in Symbol Digit Modalities Test (SDMT) and Stroop Test;Timepoint(s) of evaluation of this end point: end of trial participation / month 12 | — |
Countries
Slovakia
Contacts
Public ContactProf. MUDr. Peter Turcáni, PhD.
Lekárska fakulta UK Bratislava
Outcome results
None listed