Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease
NCT ID: NCT06081439
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
430 participants
OBSERVATIONAL
2019-09-12
2025-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients
310
No interventions assigned to this group
controls
120
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Recidive of Graves' disease
* Pregnancy
Controls: -Thyroid disease
* Neurological disease
18 Years
72 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Helena Filipsson, ass prof
Role: 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
Locations
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Endokrina Forskningsenheten, Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ImmunoGraves wp2
Identifier Type: -
Identifier Source: org_study_id
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