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The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine screening group | Experimental | consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2) |
|
| physician-driven screening group | Active Comparator | consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| routine screening | Other | routine screening for advanced NASH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of presumed advanced NASH based on biochemical and FibroScan results | Percent of participants identified with presumed advanced NASH. Specific details for calculating the primary outcome of this study are blinded for health care providers, and therefore not disclosed in this description. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of study participants with presumed high grade fibrosis | Proportion of study participants with presumed any NASH (fibrosis-4 index >2.67 or NAFLD fibrosis score >0.675 AND FibroScan LSM ≥ 8.0 kPa) | 3 months |
| Proportion of study participants with presumed any NASH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Chu, PhD | Contact | 416-268-8787 | lisa.chu@LMC.ca |
| Name | Affiliation | Role |
|---|---|---|
| Harpreet Bajaj, MD | LMC Diabetes & Endocrinology Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Diabetes & Endocrinology Ltd. | Recruiting | Toronto | Ontario | M4G 3E8 | Canada |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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The care provider is masked to the primary outcome of the study, but not masked to the intervention.
| physician-driven screening |
| Other |
physician-driven screening for advanced NASH |
|
Proportion of study participants with presumed any NASH (fibrosis-4 index ≥1.3 or NAFLD fibrosis score >-1.455 AND FibroScan diagnosis of any stage fibrosis) |
| 3 months |
| Proportion of study participants with presumed F2/F3 NASH | Proportion of study participants with presumed F2/F3 NASH (fibrosis-4 index ≥1.3 or NAFLD fibrosis score >-1.455 AND FibroScan diagnosis of F2/F3 fibrosis) | 3 months |
| Proportion of study participants with a fibrosis-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values | Proportion of study participants with a fibrosis-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values (FIB-4 ≥1.3 or/and NFS >-1.455) | 1 day |
| Proportion of study participants with a fibrosis and/or steatosis (stages) | Proportion of study participants with a fibrosis and/or steatosis (stages) based on FibroScan results | 1 day |
| Alcohol consumption by study arm - drinks per day | Alcohol consumption measured as self-reported average drinks per day | 1 day |
| Alcohol consumption by study arm - drinks per week | Alcohol consumption measured as self-reported average drinks per week | 1 day |
| Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score | Alcohol consumption measured with the Alcohol Use Disorders Identification Test (AUDIT). AUDIT scores range from a minimum score of 0 to a maximum score of 40, with higher scores indicating a worse outcome. | 1 day |
| Health-related quality of life by study arm | Health-related quality of life determined by the chronic liver disease questionnaire for non-alcoholic steatohepatitis (CLDQ-NASH) calculated as total CLDQ-NASH score. The CLDQ-NASH instrument includes 36 items grouped into six domains: abdominal symptoms; activity/energy; emotional health; fatigue; systemic symptoms; and worry. The average of the domain scores (min: 1, max: 7) yields the total CLDQ-NASH score. The minimum possible total score is 1 and the maximum possible total score is 7, with a higher total score indicating a better outcome. | 1 day |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |