Clinical trial NCT05029583: Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonalcoholic Steatohepatitis
Type 2 Diabetes
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prevalence of presumed advanced NASH based on biochemical and FibroScan results
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of study participants with presumed high grade fibrosis
timeFrame: 3 months
measure: Proportion of study participants with presumed any NASH
timeFrame: 3 months
measure: Proportion of study participants with presumed F2/F3 NASH
timeFrame: 3 months
measure: Proportion of study participants with a fibrosis-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values
timeFrame: 1 day
measure: Proportion of study participants with a fibrosis and/or steatosis (stages)
timeFrame: 1 day
measure: Alcohol consumption by study arm - drinks per day
timeFrame: 1 day
measure: Alcohol consumption by study arm - drinks per week
timeFrame: 1 day
measure: Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score
timeFrame: 1 day
measure: Health-related quality of life by study arm
timeFrame: 1 day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Endocrinology Ltd.
state: Ontario
Study officials:
affiliation: LMC Diabetes & Endocrinology Ltd.
name: Harpreet Bajaj, MD
role: PRINCIPAL_INVESTIGATOR
References: