Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease

NCT06081439 | Recruiting

• 1 other identifier: ImmunoGraves wp2
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graves Disease; Mental Fatigue

Outcome Measures

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.

  Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.

Secondary Outcomes (31)

• 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

  Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.

• 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

  Cerebrospinal fluid drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion

• 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

  Blood drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.

• 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

  Cerebrospinal fluid drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.

• Levels of thyroid hormones at inclusion compared in patients with high and low scores at the Mental Fatigue Scale at follow-up

  Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.

Study Arms (2)

patients

310

controls

120

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Recently diagnosed Graves' disease
• Positive thyroid stimulating hormone (TSH)-receptor antibodies (TRAb)
• Thyroid hormones above the upper reference limit
• Controls: Matched for gender and age

You may not qualify if:

• Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.
• Recidive of Graves' disease
• Pregnancy
• Controls: -Thyroid disease
• Neurological disease

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Endokrina Forskningsenheten, Sahlgrenska University Hospital

Gothenburg, 41346, Sweden

RECRUITING

MeSH Terms

Conditions

Graves Disease; Mental Fatigue

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Helena Filipsson, ass prof

  Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Department of Endocrinology, Sahlgrenska University Hospital, Wallenberg Center for Molecular and Translational Medicine, all in Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Tammelin, PhD student

CONTACT

+46313427331; karin.tammelin@vgregion.se

Helena Filipsson, ass prof

CONTACT

helena.filipsson@medic.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 13, 2023
• Study Start: September 12, 2019
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

SE (1)