G35 G36.0
Conditions
Interventions
Group 1: People with multiple sclerosis
Group 2: Healthy controls
Group 3: People with neuromyelitis optica spectrum disorders (NMOSD)
Sponsors
Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin and Max-Delbrück-Zentrum Berlin, Berlin, Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: For all participants: - Body mass index 19 - 35 kg/m2 - Ability to give consent - Existing health insurance for clarification and treatment of possible incidental findings For people with multiple sclerosis (MS): - Relapsing-remitting multiple sclerosis according to the MS diagnosis criteria according to McDonald 2024 - EDSS 6 months prior to inclusion - Clinical or radiologic disease activity within the last 4 years prior to study entry (defined as at least one new lesion on brain MRI and/or at least one clinical episode) For people with neuromyelitis optica spectrum disorders (NMOSD): - Aquaporin-4 antibody seropositive NMOSD according to the current IPND criteria - EDSS 6 months prior to inclusion - Clinical or radiologic disease activity within the last 4 years prior to study entry (defined as at least one new lesion on brain / spinal cord/ optic nerve MRI and/or at least one clinical episode)
Exclusion criteria
Exclusion criteria: For all participants: - Diseases or functional disorders which, in the opinion of the study physician, preclude participation in the study - Autoimmune diseases (except multiple sclerosis) - Diabetes mellitus type 2 or other clinically relevant metabolic diseases - Postoperative phases - Acute and chronic infections - Cancer - Malnutrition - Eating disorders - Eye diseases that may affect retinal structures - Pregnancy and breastfeeding - Implementation of a diet or weight reduction program - Change in body weight of more than 5 kg in two months before the start of the study - Known medication, drug or alcohol abuse - Traveling through more than one time zone within the last month - Shift work - Incapacity or other circumstances that do not allow the subject to fully understand the nature, meaning and scope of this study For people with multiple sclerosis: - Starting or changing immunomodulatory therapy during the study - Clinical relapse event and/or glucocorticoid therapy < 4 weeks prior to inclusion - Expired optic neuritis - Glucocorticoid therapy during the relapse <4 weeks before inclusion Additional exclusion criteria MRI With regard to the magnetic resonance imaging examination, persons with MRI contraindications are excluded, e.g. - Sensorineural hearing loss from 30 dB or tinnitus disease - Metallic implants, e.g. bone plates, joint prostheses, artificial anus with magnetic closure, vascular clips, artificial heart valves, stents, vena cava filters - Wearing electronic devices, e.g. pacemakers or cochlear implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase and amplitude of circadian rhythm as well as frequency of immune cell subsets (CD4 and CD8+ cells, B cells, monocytes, dendritic cells, NK cells), in 4-hour intervals during a 24h observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| • Circadian rhythm of metabolic (blood glucose, adipocine, blood lipids) and immunological markers (Number and frequency of leukocytes in the peripheral blood, cytokines/chemokines) and clock genes in isolated monocytes • integrity of the retina-hypothalamic axis (pupillometry, optical coherence tomography) • Anthropometric parameters (height, weight, hip and waist circumference, fat percentage, measured by bioimpedance analysis) • Increased lesion load and microstructural damage contribute to symptom burden in NMOSD and MS (measured by MRI). • Four weeks of TRE (time-restricted eating) after a four-week baseline improves metabolic parameters and their rhythms (blood glucose, adipokines, blood lipids), immunological status (cytokine/chemokine levels in blood plasma), and neurological symptoms (fatigue, sleep quality) in patients with MS and NMOSD, but not in healthy controls. • Nutritional data: energy intake, food composition, meal times • Glucose values, measured in plasma and in interstitial fluid using glucose sensors over a 24-hour period and in the oral glucose tolerance test (OGTT) • Insulin levels, measured in plasma over the course of 24 hours and in the OGTT • Hormone levels (leptin, adiponectin, PYY, ghrelin) measured in plasma over the course of 24 hours • Blood lipids (total, HDL, LDL cholesterol, triglycerides, free fatty acids), measured in plasma over the course of 24 hours • Cytokine and chemokine levels (e.g. IL-6, TNF alpha, IFN gamma, IL-17) over the course of 24 hours • Neurofilament Light (NfL) values over the course of 24 hours • Gene expression in isolated blood monocytes, measured by RNA-Seq over the course of 24 hours • Expression of subtype markers (e.g. iNOS, CD40, CD80) and cytokine and chemokine secretion (e.g. CCL2, CCL3, IL-12) in the medium of ex vivo differentiated M1/M2 macrophage culture • Degree of disability in people using the Expanded disability status scale • Thickness of the retinal ganglion cell inner plex | — |
Countries
Germany
Contacts
Public ContactFrederike Cosima Oertel
Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin und Max-Delbrück-Zentrum Berlin
Outcome results
None listed