Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05678374
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-12-19
Brief Title:
Exploring Immunological Markers Associated With Mental Fatigue in Graves Disease
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Exploring Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Euthyroidism After Graves Disease- a Cross Sectional Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None