Actively Recruiting
Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease
Led by Vastra Gotaland Region · Updated on 2024-11-18
430
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Unable to follow protocol due to psychosis, dementia, or inability to answer questionnaires in Swedish
- Recurrence of Graves' disease
- Pregnancy
- Controls with thyroid disease
- Neurological disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Endokrina Forskningsenheten, Sahlgrenska University Hospital
Gothenburg, Sweden, 41346
Actively Recruiting
Research Team
K
Karin Tammelin, PhD student
CONTACT
H
Helena Filipsson, ass prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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