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

LMC Diabetes & Endocrinology Ltd.

Status: Enrolling

Conditions: Type 2 Diabetes; Nonalcoholic Steatohepatitis

Treatments: Other: physician-driven screening; Other: routine screening

Study type: Interventional

Funder types: Other

Identifiers

NCT05029583

SCREEN NASH T2D

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,000 participants in 2 patient groups

routine screening group

Experimental group

Description:

consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2)

Treatment:

Other: routine screening

physician-driven screening group

Active Comparator group

Description:

consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1)

Treatment:

Other: physician-driven screening