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

Last updated: January 23, 2024
Sponsor: LMC Diabetes & Endocrinology Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetes Prevention

Treatment

routine screening

physician-driven screening

Clinical Study ID

NCT05029583
SCREEN NASH T2D
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Known history of biopsy-proven NAFLD or NASH, hepatitis B, hepatitis C, HIV, livercirrhosis, hemochromatosis, drug-induced hepatitis, alcohol-related or autoimmunehepatic disease, history of hepatic decompensation, solid organ transplant, or primaryliver cancer, based on electronic medical record
  • History of alcohol abuse (≥30 g/day or ≥3 drinks/day for males and ≥20 g/day or ≥2drinks/day for females)
  • Unstable patients with T2D (e.g. end stage renal disease on dialysis, late stagecancer, 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 cannotbe performed)
  • Language barriers (i.e. inability to read the consent form translated in any of themultiple languages)

Study Design

Total Participants: 5000
Treatment Group(s): 2
Primary Treatment: routine screening
Phase:
Study Start date:
August 11, 2021
Estimated Completion Date:
October 05, 2025

Study 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.

Connect with a study center

  • LMC Diabetes & Endocrinology Ltd.

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

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