Exploring immune markers linked to mental fatigue in Graves' disease
Validating Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Graves' Disease and Their Association With Functional Changes in Neuronal Activation
This study looks at whether certain immune markers are linked to ongoing mental fatigue in people with Graves' disease after their thyroid levels are back to normal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 430 (estimated) |
| Ages | 18 Years to 72 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06081439 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between immunological markers and mental fatigue in patients diagnosed with Graves' disease. It aims to confirm the association of these markers with persistent mental fatigue after achieving normal thyroid function. A total of 310 patients will be assessed for various psychological and physical symptoms at different stages of their treatment, including before and after achieving euthyroidism. Blood and cerebrospinal fluid samples will be collected to analyze the identified biomarkers alongside thyroid hormones and autoantibodies.
Who should consider this trial
Good fit: Ideal candidates are individuals recently diagnosed with Graves' disease who have elevated thyroid hormones and positive TSH-receptor antibodies.
Not a fit: Patients with pre-existing neurological diseases, psychosis, or those unable to complete questionnaires in Swedish 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 specific approach of this study is novel, similar studies exploring the link between autoimmune conditions and mental health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recently diagnosed Graves' disease * Positive thyroid stimulating hormone (TSH)-receptor antibodies (TRAb) * Thyroid hormones above the upper reference limit * Inclusion within three weeks after start of antithyroid drugs Controls: Matched for gender and age Exclusion Criteria: * Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish. * Recidive of Graves' disease * Pregnancy Controls: -Thyroid disease * Neurological disease
Where this trial is running
Gothenburg
- Endokrina Forskningsenheten, Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Helena Filipsson, ass prof — Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Department of Endocrinology, Sahlgrenska University Hospital, Wallenberg Center for Molecular and Translational Medicine, all in Gothenburg, Sweden
- Study coordinator: Karin Tammelin, PhD student
- 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.