Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062525) titled 'A study of whether, among older adults, recorded COVID-19 is associated with a sustained change in a measured glycemic marker (HbA1c) from before to after infection, compared with people without recorded COVID-19, using health check-up and claims measurements' on Aug. 9.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - COVID-19 (exposure) and change in glycemia (HbA1c) / incident diabetes (outcome), among late-elderly adults without pre-existing diabetes. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using linked data from Japan Late-Stage Elderly Medical Care System (enrollment, claims, dispensing, care-related, and health check-up records through March 2025), to estimate whether recorded COVID-19 is associated with the change in HbA1c from before (about 12 months before index) to after (about 12 months after index) infection, among adults aged 65 years or older without pre-existing diabetes and with baseline HbA1c below 6.5%, within a risk-set-matched difference-in-differences framework, compared with matched controls without recorded COVID-19. Death, disenrollment, and observation are handled explicitly using observation weighting (IPOW/AIPW). Basic objectives2 - Others

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Adults aged 65 years or older in linked data from the Japan Late-Stage Elderly Medical Care System (enrollment, medical/dispensing/care-related claims, and health check-up records through March 2025). (2) At least 24 months of continuous enrollment. (3) A baseline HbA1c measured 9 to 15 months before index and below 6.5%. (4) No recorded diabetes diagnosis or glucose-lowering medication in the prior 24 months. The source extract was selected for respiratory-related medical contact or systemic anti-infective treatment, and the primary cohort required that extract-entry evidence to precede index. The exposure group is first recorded COVID-19 (confirmed nonsuspected diagnosis plus SARS-CoV-2 testing, COVID-19 hospitalization, diagnosis plus an eligible antiviral, or an eligible antiviral alone; eligible antivirals were molnupiravir, ensitrelvir, and nirmatrelvir/ritonavir). Controls had no recorded COVID-19 by the matched index date. Frozen exact-index-month matched sets were restricted to index dates through December 2023. Key exclusion criteria - (1) A recorded diabetes diagnosis or glucose-lowering medication in the prior 24 months. (2) A baseline HbA1c not measured 9 to 15 months before index, or 6.5% or higher. (3) Less than 24 months of continuous enrollment. (4) An index date after December 2023. Target Size - 68820

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 04 Month 14 Day Last follow-up date - 2026 Year 08 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071572

Disclaimer: Curated by HT Syndication.