Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059974) titled 'Misleading Islet Markers in Cases Treated with Immunoglobulin Therapy' on Jan. 1.

Study Type: Observational

Primary Sponsor: Institute - Chiba University

Condition: Condition - Diseases treated with immunoglobulin therapy, such as myasthenia gravis and idiopathic thrombocytopenic purpura Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to determine the proportion of patients who become positive for islet-related autoantibodies after immunoglobulin administration by measuring islet-related autoantibodies (GAD antibody, IA-2 antibody, insulin antibody, and ZnT8 antibody) before and after immunoglobulin therapy. Another purpose is to determine how long it takes for patients who become positive for islet-related autoantibodies to become negative. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1) Patients who are scheduled to receive immunoglobulin therapy for diseases such as myasthenia gravis and idiopathic thrombocytopenic purpura. 2) Patients who have received a full explanation of and fully understood the details of participating in this study and have voluntarily provided written consent. Key exclusion criteria - Patients who meet any of the following criteria are ineligible to participate in this study. 1) Patients who have received immunoglobulin therapy within the past six months. 2) Patients who have been diagnosed with diabetes. 3) Patients with one or more of the following: HbA1c 6.5% or higher, fasting blood glucose 126 mg/dL or higher, or casual blood glucose 200 mg/dL or higher. 4) Patients who tested positive for islet-associated autoantibodies (GAD antibody, IA-2 antibody, insulin antibody, ZnT8 antibody) before starting immunoglobulin therapy. 5) Patients who may discontinue outpatient treatment at our hospital due to reasons such as transferring to another hospital or moving within three months of obtaining consent. 6) Patients who are deemed unsuitable for the safe implementation of this study by the principal investigator or co-investigator. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 28 Day Date of IRB - 2025 Year 11 Month 28 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068586

Disclaimer: Curated by HT Syndication.