NCT05029583

Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)

A Cluster Randomized Trial to Determine Diagnostic and Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: LMC Diabetes & Endocrinology Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.

Detailed 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. 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 will undergo biochemical screening. Regardless of randomization, any participants meeting biochemical cut-offs (FIB-4 index ≥1.3 or NFS \>-1.455) will undergo FibroScans. Clinical data and a health-related quality of life assessment will also be collected.

Conditions

• Nonalcoholic Steatohepatitis
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	routine screening	routine screening for advanced NASH
OTHER	physician-driven screening	physician-driven screening for advanced NASH

Timeline

• Start date: 2021-08-11
• Primary completion: 2025-10-05
• Completion: 2025-10-05
• First posted: 2021-08-31
• Last updated: 2024-01-24

Locations

1 site across 1 country: Canada