NCT06081439 Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease
| NCT ID | NCT06081439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Graves Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 430 participants |
| Start Date | 2019-09-12 |
| Primary Completion | 2025-12-20 |
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 430 participants in total. It began in 2019-09-12 with a primary completion date of 2025-12-20.
⚠ 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 euthyroidism in Graves' disease is an autoimmune complication. This is a confirmatory study of the biomarkers from ImmunoGraves WP1 in which immunological markers with possible association with mental fatigue in Graves' disease are explored. In ImmunoGraves WP2, 310 patients with Graves' disease are assessed for symptoms of mental fatigue, quality of life, anxiety and depression, self-evaluated stress, coping strategies, personality traits, eye symptoms and background variables. Participants are examined in hyperthyroidism at inclusion, within three weeks from diagnosis, and in euthyroidism after 15 months. Serum and cerebrospinal fluid (in a subsample of participants) is collected at both visits and will be evaluated for the immunological markers identified in WP1 as well as for thyroid hormones, thyroid autoantibodies and biomarkers indicating organic and structural nerve damage. Significant predictors for mental fatigue will be identified by logistic regression. To assess functional changes in the brain, magnetoencephalography will be performed in a subset of patients and in healthy controls at inclusion and after 15 to 18 months. Combined with magneto resonance imaging (MRI), magnetoencephalography gives information on neuronal activation during attention testing.
Eligibility 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
Contact & Investigator
Helena Filipsson, ass prof
PRINCIPAL INVESTIGATOR
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
Frequently Asked Questions
Who can join the NCT06081439 clinical trial?
This trial is open to participants of all sexes, 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 NCT06081439 currently recruiting?
Yes, NCT06081439 is actively recruiting participants. Contact the research team at karin.tammelin@vgregion.se for enrollment information.
Where is the NCT06081439 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06081439 clinical trial?
NCT06081439 is sponsored by Vastra Gotaland Region. The principal investigator is Helena Filipsson, ass prof at 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. The trial plans to enroll 430 participants.