Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061447) titled 'A retrospective study of clinical characteristics and therapeutic interventions in patients with GAD antibody-positive diabetes' on May 11.

Study Type: Observational

Primary Sponsor: Institute - Kimitsu Chuo Hospital

Condition: Condition - Diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In patients with diabetes who are positive for anti-GAD antibodies, pancreatic B-cells are gradually destroyed, leading to impaired insulin secretion. Therefore, in determining treatment strategies, it is important to consider B-cell-preserving therapies and the use of intensive insulin therapy. In recent years, advances in research on the pathogenesis of type 1 diabetes have led to the proposal of a staging classification based on islet autoantibodies, including anti-GAD antibodies, and glycemic indices. This framework highlights the importance of earlier intervention. Stage 1: Presence of two or more autoantibodies with normoglycemia Stage 2: Presence of one or more autoantibodies with dysglycemia (asymptomatic) Stage 3: Overt diabetes with hyperglycemia; autoantibodies may become negative over time In Japan, under the national health insurance system, measurement of autoantibodies is reimbursed only at Stage 3. At our hospital, anti-GAD antibodies have been measured in all patients at their initial visit as part of screening for type 1 diabetes, and the results have been utilized in determining treatment strategies. In this study, we retrospectively analyzed the clinical data accumulated at our hospital with the aim of clarifying the following three points: 1. The prevalence of anti-GAD antibody-positive patients 2. Clinical characteristics of anti-GAD antibody-positive patients (including complications) 3. Treatment interventions implemented in anti-GAD antibody-positive patients Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients tested for anti-GAD antibodies at our hospital were included. Because the measurement method and reference range for anti-GAD antibodies were changed in December 2015, the study period was defined as the 10 years from January 2016 to December 2025. Key exclusion criteria - None. Target Size - 3000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Date of IRB - 2026 Year 04 Month 17 Day Anticipated trial start date - 2026 Year 04 Month 17 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070212

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