Endothelial Dysfunction in Post-infection Fatigue Syndromes
- Conditions
- Long COVIDChronic Fatigue Syndrome
- Registration Number
- NCT06463106
- Lead Sponsor
- FH Joanneum Gesellschaft mbH
- Brief Summary
Post-infection chronic fatigue syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID-19 condition (Long Covid), are conditions primarily characterized by debilitating fatigue. This fatigue can range from mild, where patients are still able to participate in some social activities (e.g., school, work), to moderate and severe, where sufferers are predominantly homebound and bedridden. As a result, ME/CFS and Long Covid not only negatively impact the quality of life of affected individuals and their caregivers but also represent a substantial and often silent burden on healthcare systems worldwide, including Austria. This is primarily because most cases remain undiagnosed due to the lack of standardized clinical assessments and diagnostic markers. Endothelial dysfunction, which is well known to affect blood flow, oxygen and nutrient delivery, and waste removal in the body, has been described as one of the key factors behind the symptoms experienced by ME/CFS and Long Covid patients. However, the mechanisms that might explain the development of endothelial dysfunction remain largely unexplored. Therefore, this project aims to evaluate key biological aspects related to the function of endothelial cells - a layer of cells lining blood vessels - using plasma samples from an Austrian cohort of ME/CFS and Long Covid patients. We expect that the findings from our study will provide new insights to better understand endothelial dysfunction in post-infection chronic fatigue syndromes, leading to improved patient stratification and tailored treatment alternatives.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
The inclusion criteria for ME/CFS patients not infected with SARS-CoV-2 (n=17; females: 70.59%; age (years): 40.10 ± 10.80) and Long-Covid patients (n=30; females: 73.4%; age (years): 37.70 ± 9.96) include profound fatigue and at least one of the following symptoms: PEM, autonomic dysfunction, and/or orthostatic intolerance. All participants were included only if they were at least 12 weeks past an acute EBV infection and/or 10 weeks past an acute SARS-CoV-2 infection, respectively. SARS-CoV-2 specific IgA (A) and IgG (B) antibody titers were measured using commercial test kits (Anti-SARS-CoV-2-ELISA (IgA) and Anti-SARS-CoV-2-QuantiVac-ELISA (IgG); Euroimmun, Germany) in plasma samples.
Participants' exclusion criteria included evidence of acute malignant diseases, diabetes mellitus, acute sepsis, chronic inflammatory gastrointestinal diseases, and frequent intake of analgesics, antacids, or antibiotics. Furthermore, no previously hospitalized SARS-CoV-2 patients were included, eliminating false-positive fatigue due to intensive care treatment, such as artificial respiration.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circulating levels of L-arginine metabolites 6 months Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS)
Markers of endothelial inflammation 6 months ELISA
Endothelial permeability 6 months 3D culture model
Angiogenesis 6 months 3D culture model
Epigenetic and transcriptomic patterns in endothelial cells 6 months Genome wide DNA methylation and RNA sequencing (RNA-seq)
Production of reactive oxygen species (ROS) in endothelial cells 6 months Fluorometric assay
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FH JOANNEUM University of Applied Sciences
🇦🇹Graz, Austria