NCT05678374 Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
| NCT ID | NCT05678374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Graves Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2028-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2019-10-01 with a primary completion date of 2028-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2). Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.
Eligibility Criteria
Inclusion Criteria * If patient: Graves' disease with positive TSH-receptor antibodies and thyroid hormones above the upper reference limit at diagnosis * Diagnosis15 to 60 months ago. If recidive both episodes must have occurred within 15 months to 60 months. * Thyroid hormones within normal range without anti thyroid drugs * If control: No thyroid disease * Patient and control without mental fatigue: Mental Fatigue Score ≤8 (cut off 10.5) * Patient with mental fatigue: Mental Fatigue Score \>13 and debut of symptoms of mental fatigue in parallel with debut of Graves' disease, without other obvious cause Exclusion Criteria * Person unable to follow protocol * Multiple sclerosis, myalgic encephalomyelitis/chronic fatigue syndrome, any other neurological disease * Traumatic brain injury with unconsciousness * Other disease strongly associated with fatigue * Pregnancy and breast-feeding * On-going or recent systemic treatment with steroids * Radioiodine therapy within the last 18 months
Contact & Investigator
Helena Filipsson
PRINCIPAL INVESTIGATOR
Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
Frequently Asked Questions
Who can join the NCT05678374 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 72 Years, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05678374 currently recruiting?
Yes, NCT05678374 is actively recruiting participants. Contact the research team at karin.tammelin@vgregion.se for enrollment information.
Where is the NCT05678374 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT05678374 clinical trial?
NCT05678374 is sponsored by Vastra Gotaland Region. The principal investigator is Helena Filipsson at Institute of Medicine, Sahlgrenska Academy, University of Gothenburg. The trial plans to enroll 180 participants.