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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029583
• Other study ID #: SCREEN NASH T2D
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: October 5, 2025

Study information

• Verified date: January 2024
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: Lisa Chu, PhD
• Phone: 416-268-8787
• Email: lisa.chu[@]LMC.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 5, 2025
• Est. primary completion date: October 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis
• Type 2 Diabetes

Intervention

Other:
• routine screening
routine screening for advanced NASH
• physician-driven screening
physician-driven screening for advanced NASH

Locations

Country	Name	City	State
Canada	LMC Diabetes & Endocrinology Ltd.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Alcohol consumption by study arm - drinks per day	Alcohol consumption measured as self-reported average drinks per day	1 day
Secondary	Alcohol consumption by study arm - drinks per week	Alcohol consumption measured as self-reported average drinks per week	1 day
Secondary	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
Secondary	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