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

LMC Diabetes & Endocrinology Ltd.5,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

5,000

Conditions

Nonalcoholic Steatohepatitis Type 2 Diabetes

Interventions

routine screeningOTHER

routine screening for advanced NASH

physician-driven screeningOTHER

physician-driven screening for advanced NASH

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 1 day

Central Contacts

Lisa Chu, PhD

CONTACT

416-268-8787 lisa.chu@LMC.ca

Data from ClinicalTrials.gov

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