Exploring immune markers linked to mental fatigue in Graves' disease
Exploring Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Euthyroidism After Graves' Disease- a Cross Sectional Study
This study is testing how certain immune markers are connected to mental fatigue in people with Graves' disease to better understand their experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 72 Years |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05678374 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between immunological markers and mental fatigue in patients with Graves' disease. It will involve a cross-sectional design where 60 patients experiencing mental fatigue and 60 without it will be assessed 15-60 months post-diagnosis. Participants will complete questionnaires to evaluate mental fatigue, and their thyroid hormones, quality of life, anxiety, depression, and other variables will be measured. The study will utilize advanced profiling techniques to analyze serum and cerebrospinal fluid for potential biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Graves' disease who have positive TSH-receptor antibodies and exhibit symptoms of mental fatigue.
Not a fit: Patients with neurological diseases, traumatic brain injuries, or other conditions strongly associated with fatigue may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of mental fatigue in patients with Graves' disease.
How similar studies have performed: While the exploration of immunological markers in relation to mental fatigue is a relatively novel approach, similar studies have shown promise in understanding autoimmune conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg
- Department of Endocrinology, Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Helena Filipsson — Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
- Study coordinator: Karin Tammelin
- Email: karin.tammelin@vgregion.se
- Phone: +46313427331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.