Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-72
SponsorVastra Gotaland Region
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.
Recidive of Graves' disease
Pregnancy
Neurological disease
Trial population
310 patients with Graves' are recruited from Endocrine Clinic at Sahlgrenska University Hospital and Östra Hospital. Patients meeting the inclusion criteria are consecutively asked to participate. A subgroup of maximum 120 patients who are willing to give cerebrospinal fluid are recruited to the sub-study with magnetoencephalography. Controls to this sub-study are recruited from records from the tax authority.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
430 Participants
are grouped into 2 trial groupsGroup A: patients
Group B: controls
Trial outcomes
Primary outcomes
1
Identifying the immunological markers in blood at inclusion that significantly increases the risk for mental fatigue at follow up.
Immunological markers in blood identified in the on-going study ImmunoGraves Wp1 are analysed between participants who at follow up have 10.5 points or more at the Mental Fatigue Scale and participants who have less than 10.5 points at the Mental Fatigue Scale. Higher scores at the Mental Fatigue Scale means more brain fatigue.
Time frame
Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.Secondary outcomes
1
Levels of the previously identified immunological markers in serum at inclusion compared between participants who at follow up have high scores at the Mental Fatigue Scale and participants who at follow up have low scores at the Mental Fatigue Scale
Immunological markers identified in the on-going study ImmunoGraves Wp1 are compared between participants who at follow up have 10.5 points or more at the Mental Fatigue Scale and participants who have less than 10.5 points at the Mental Fatigue Scale.Higher scores at the Mental Fatigue Scale means more brain fatigue.
Time frame
Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.2
Levels of the previously identified immunological markers in cerebrospinal fluid at inclusion compared between patients with high and low scores at the Mental Fatigue Score at follow-up
Immunological markers identified in the on-going study ImmunoGraves Wp1 are compared between participants who at follow up have 10.5 points or more at the Mental Fatigue Scale and participants who have less than 10.5 points at the Mental Fatigue Scale.Higher scores at the Mental Fatigue Scale means more brain fatigue.
Time frame
Cerebrospinal fluid drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion3
Levels of the previously identified immunological markers in serum at follow up compared between patients with high and low scores at the Mental Fatigue Scale at follow-up and to healthy controls
Immunological markers identified in the on-going study ImmunoGraves Wp1 are compared between participants who at follow-up have 10.5 points or more at the Mental Fatigue Scale and participants who have less than 10.5 points at the Mental Fatigue Scale. Higher scores at the Mental Fatigue Scale means more brain fatigue.
Time frame
Blood drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.4
Levels of the previously identified immunological markers in cerebrospinal fluid at follow up compared between patients with high and low scores at the Mental Fatigue Scale at follow-up
Immunological markers identified in the on-going study ImmunoGraves Wp1 are compared between participants who at follow-up have 10.5 points or more at the Mental Fatigue Scale and participants who have less than 10.5 points at the Mental Fatigue Scale. Higher scores at the Mental Fatigue Scale means more brain fatigue.
Time frame
Cerebrospinal fluid drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov