Actively Recruiting

Age: 18Years - 72Years
FEMALE
Healthy Volunteers
NCT05678374

Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Led by Vastra Gotaland Region · Updated on 2025-09-29

180

Participants Needed

1

Research Sites

481 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 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

Official Title

Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Who Can Participate

Age: 18Years - 72Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Graves' disease with positive TSH-receptor antibodies and thyroid hormones above the upper reference limit at diagnosis
  • Diagnosis 15 to 60 months ago; if recurrence, both episodes must have occurred within this time frame
  • Thyroid hormones within normal range without anti-thyroid drugs
  • Controls must have no thyroid disease
  • Patients and controls without mental fatigue must have a Mental Fatigue Score of 8 or less
  • Patients with mental fatigue must have a Mental Fatigue Score above 13 with symptoms starting alongside Graves' disease and no other obvious cause
Not Eligible

You will not qualify if you...

  • Unable to follow the study protocol
  • Diagnosed with multiple sclerosis, myalgic encephalomyelitis/chronic fatigue syndrome, or any other neurological disease
  • History of traumatic brain injury with unconsciousness
  • Other diseases strongly linked to fatigue
  • Pregnant or breastfeeding
  • Currently or recently treated with systemic steroids
  • Received radioiodine therapy within the last 18 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Endocrinology, Sahlgrenska University Hospital

Gothenburg, Sweden, 41346

Actively Recruiting

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Research Team

K

Karin Tammelin

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

3

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Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease | DecenTrialz