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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05678374
Other study ID # ImmunoGraves WP1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date December 20, 2024

Study information

Verified date March 2024
Source Vastra Gotaland Region
Contact Karin Tammelin
Phone +46313427331
Email karin.tammelin@vgregion.se
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 20, 2024
Est. primary completion date December 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 72 Years
Eligibility 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

Study Design


Locations

Country Name City State
Sweden Department of Endocrinology, Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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 Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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). Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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) Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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) Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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). Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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). Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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. Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
Secondary 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). Patients and controls will be examined at one occasion, for patients 15-60 months after diagnosis of Graves' disease.
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