Graves DiseaseNCT05678374
Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
An observational study of Graves Disease and Graves Ophthalmopathy, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Graves Disease, Graves Ophthalmopathy, Mental Fatigue
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2019to 18 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited from the both previous patients at the Endocrine outpatient Clinic at Sahlgrenska University Hospital in Gothenburg and from advertising. They are invited to a web based screening form where the ones eligible are contacted by study personal and eligibility criteria are checked again. Controls are recruited by the same way and by contacting a random sample from the population registration (based on Swedish social security number). Groups are matched for age, educational level and smoking habits.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Endocrinology, Sahlgrenska University Hospital
Gothenburg, 41346
About this study
Official title: Exploring Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Euthyroidism After Graves' Disease- a Cross Sectional Study
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
- Keywords
- Biomarkers, Cerebrospinal fluid in Graves' disease
- Medical subject headings
- Graves Disease, Graves Ophthalmopathy, Mental Fatigue, Autoimmune Diseases, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| 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) | |
| Thyroid healthy controls without mental fatigue | Women without current or previous thyroid disease and with Mental Fatigue Scale scores of less than 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease complicated by mental fatigue than in Graves' disease not complicated by mental fatigue
Each group will be analysed in arrays for antibodies targeting 42000 human proteins (ScilifeLabs, Stockholm). Proteins binding to antibodies in mental fatigue patients will be screened against the Human Protein Atlas (www.proteinatlas.org) and the Allen brain map (www.brain-map.org) and those expressed in the brain will be compared between groups.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary outcomes (15)
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease complicated by mental fatigue than in thyroid healthy controls without mental fatigue
Each group will be analysed in arrays for antibodies targeting 42000 human proteins (ScilifeLabs, Stockholm). Proteins binding to antibodies in mental fatigue patients will be screened against the Human Protein Atlas (www.proteinatlas.org) and the Allen brain map (www.brain-map.org) and those expressed in the brain will be compared between groups.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease not complicated by mental fatigue than in thyroid healthy controls without mental fatigue
Each group will be analysed in arrays for Ab targeting 42000 human proteins (ScilifeLabs, Stockholm). Proteins binding to Ab in MF patients will be screened against the Human Protein Atlas (www.proteinatlas.org) and the Allen brain map (www.brain-map.org) and those expressed in the brain will be compared between groups.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Thyroid autoantibodies compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Levels of thyroid autoantibodies will be analysed with the standard method of the laboratory at Sahlgrenska University Hospital.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Cytokines compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Levels of cytokines will be analysed with the standard method of the laboratory at Sahlgrenska University Hospital.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Biomarkers indicating organic and structural nerve damage compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Biomarkers will be analysed with the standard method of the laboratory at Sahlgrenska University Hospital.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Autoantibodies to other g-protein coupled receptors compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Levels of autoantibodies to g-protein coupled receptors will be measured using enzyme-linked immunosorbent assays
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Prevalence of endocrine ophthalmopathy in Graves' complicated by mental fatigue compared to prevalence of endocrine ophtalmopathy in Graves' not complicated by mental fatigue
Prevalence defined as endocrine ophthalmopathy that has required assessment/and or follow up at ophthalmologist.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated quality of life in relation to ophthalmopathy will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated quality of life in relation to thyroid symptoms will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated quality of life and well being will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire Psychological General Well Being index (PGWB)
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated symptoms of anxiety and depression will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS).
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated stress will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14).
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Coping strategies will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire Brief cope.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Optimistic self-beliefs to cope with difficulties in life will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire General self efficacy.
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Personality traits will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Evaluated by the validated questionnaire NEO Five-Factor Inventory-3 (NEO-FFI-3).
Measured: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Oct 2019
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Why it stopped: We had initially planned to include 60 participants per group. However, due to substantial difficulties with participant recruitment, we decided to close the study after enrolling 39, 15, and 40 participants in the respective groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Helena Filipsson, Principal investigator, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678374
- Sponsor's protocol ID
- ImmunoGraves WP1
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Euthyroidism After Graves' Disease- a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05678374
- Acronym / sponsor ID
- ImmunoGraves WP1
- Conditions
- Graves Disease, Graves Ophthalmopathy, Mental Fatigue, Autoimmune Diseases, Thyroid Diseases
- Keywords
- Biomarkers, Cerebrospinal fluid in Graves' disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We had initially planned to include 60 participants per group. However, due to substantial difficulties with participant recruitment, we decided to close the study after enrolling 39, 15, and 40 participants in the respective groups.
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
| 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) |
| Thyroid healthy controls without mental fatigue | – | –Women without current or previous thyroid disease and with Mental Fatigue Scale scores of less than 8 |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from the both previous patients at the Endocrine outpatient Clinic at Sahlgrenska University Hospital in Gothenburg and from advertising. They are invited to a web based screening form where the ones eligible are contacted by study personal and eligibility criteria are checked again. Controls are recruited by the same way and by contacting a random sample from the population registration (based on Swedish social security number). Groups are matched for age, educational level and smoking habits.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease complicated by mental fatigue than in Graves' disease not complicated by mental fatigue
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Each group will be analysed in arrays for antibodies targeting 42000 human proteins (ScilifeLabs, Stockholm). Proteins binding to antibodies in mental fatigue patients will be screened against the Human Protein Atlas (www.proteinatlas.org) and the Allen brain map (www.brain-map.org) and those expressed in the brain will be compared between groups.
15 secondary outcomes
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease complicated by mental fatigue than in thyroid healthy controls without mental fatigue
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease not complicated by mental fatigue than in thyroid healthy controls without mental fatigue
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Thyroid autoantibodies compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Cytokines compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Biomarkers indicating organic and structural nerve damage compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Autoantibodies to other g-protein coupled receptors compared between Graves' disease complicated by mental fatigue, Graves' disease not complicated by mental fatigue and healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Prevalence of endocrine ophthalmopathy in Graves' complicated by mental fatigue compared to prevalence of endocrine ophtalmopathy in Graves' not complicated by mental fatigue
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated quality of life in relation to ophthalmopathy will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated quality of life in relation to thyroid symptoms will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated quality of life and well being will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated symptoms of anxiety and depression will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Self evaluated stress will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Coping strategies will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Optimistic self-beliefs to cope with difficulties in life will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Personality traits will be compared between patients with Graves' with and without mental fatigue and to healthy controls
Time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Results and safety
The study was stopped early (reason given: We had initially planned to include 60 participants per group. However, due to substantial difficulties with participant recruitment, we decided to close the study after enrolling 39, 15, and 40 participants in the respective groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Filipsson principal investigator
Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease and Graves Ophthalmopathy, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We had initially planned to include 60 participants per group. However, due to substantial difficulties with participant recruitment, we decided to close the study after enrolling 39, 15, and 40 participants in the respective groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying autoantibodies targeting antigens occurring in the brain that are higher in Graves' disease complicated by mental fatigue than in Graves' disease not complicated by mental fatigue (time frame: Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.