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Clinical Trial Summary

The study is stratified cluster randomized trial (Phase 1) and prospective cohort study and NASH registry (Phase 2). The study population will include adults with T2D and presumed advanced NASH.

Clinical Trial Description

The study is a multi-centered, stratified cluster randomized controlled, open-labeled two-phase study. Clusters will be independent LMC clinic sites with patients as participants. The use of the stratified cluster randomization design will help prevent the potential for cross-contamination of screening methods. The study consists of two phases. For Phase 1, study participants who meet eligibility criteria undergo NASH screening. Everything, other than routineness of screening, is maintained the same in both the groups. The screening intervention received is determined by the site of the participant's provider. All participants enrolled undergo biochemical screening. In Phase 2, all participants, regardless of randomization, meeting biochemical cut-offs (FIB-4 index >2.67 or NFS >0.675) will undergo FibroScans at Phase 2 initiation and at the 36-month follow-up visit. Clinical data and a health-related quality of life assessment are collected at baseline and 36 months. A prospective NASH registry will be created from the participant data collected in Phase 2. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05029583
Study type Interventional
Source LMC Diabetes & Endocrinology Ltd.
Contact Lisa Chu, PhD
Phone 416-268-8787
Email [email protected]
Status Recruiting
Phase N/A
Start date August 11, 2021
Completion date June 1, 2026

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