Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

NCT ID: NCT05678374

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2028-12-20

Brief Summary

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2).

Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.

Conditions

Graves Disease; Graves Ophthalmopathy; Mental Fatigue; Autoimmune Diseases; Thyroid Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Graves' patients with mental fatigue

Women diagnosed with Graves 15 moths to 60 months ago with Mental Fatigue Scale score of more than 13 (maximum 42, cut of 10,5 for mental fatigue)

No interventions assigned to this group

Graves' patients without mental fatigue

Women diagnosed with Graves 15 moths to 60 months ago with Mental Fatigue Scale score of less than 8 (maximum 42, cut of 10,5 for mental fatigue)

No interventions assigned to this group

Thyroid healthy controls without mental fatigue

Women without current or previous thyroid disease and with Mental Fatigue Scale scores of less than 8

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Filipsson

Role: PRINCIPAL_INVESTIGATOR

Institute of Medicine, Sahlgrenska Academy, University of Gothenburg

Locations

Department of Endocrinology, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Karin Tammelin

Role: CONTACT

karin.tammelin@vgregion.se

+46313427331

Facility Contacts

Karin Tammelin, MD

Role: primary

karin.tammelin@vgregion.se

0313427331

Other Identifiers

ImmunoGraves WP1

Identifier Type: -

Identifier Source: org_study_id