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)

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Nonalcoholic Steatohepatitis
• Intervention / Treatment: Other: routine screening; Other: physician-driven screening

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.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Chu, PhD; Phone Number: 416-268-8787; Email: lisa.chu@LMC.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3E8
      • Recruiting
      • LMC Diabetes & Endocrinology Ltd.
      • Principal Investigator: Harpreet Bajaj, MD
      • Contact: Lisa Chu, PhD; Email: lisa.chu@lmc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of T2D
• Age 18 - 80 years
• BMI >25 kg/m2 or waist circumference ≥102 cm in men and ≥88 cm in women
• Informed consent

Exclusion Criteria:

• Known history of biopsy-proven NAFLD or NASH, hepatitis B, hepatitis C, HIV, liver cirrhosis, hemochromatosis, drug-induced hepatitis, alcohol-related or autoimmune hepatic disease, history of hepatic decompensation, solid organ transplant, or primary liver cancer, based on electronic medical record
• History of alcohol abuse (≥30 g/day or ≥3 drinks/day for males and ≥20 g/day or ≥2 drinks/day for females)
• Unstable patients with T2D (e.g. end stage renal disease on dialysis, late stage cancer, acute cardiovascular event or any hospitalization in the past 3 months). Note - Emergency room visit without hospitalization is not exclusionary
• Pregnancy/lactation
• Presence of implanted electronic medical device (i.e., pacemaker, as FibroScan cannot be performed)
• Language barriers (i.e. inability to read the consent form translated in any of the multiple languages)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: routine screening group; consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2)	Other: routine screening; routine screening for advanced NASH
Active Comparator: physician-driven screening group; consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1)	Other: physician-driven screening; physician-driven screening for advanced NASH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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
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

Collaborators and Investigators

• Sponsor: LMC Diabetes & Endocrinology Ltd.
• Investigators: Principal Investigator: Harpreet Bajaj, MD, LMC Diabetes & Endocrinology Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Estimated): October 5, 2025
• Study Completion (Estimated): October 5, 2025

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SCREEN NASH T2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No