Recruiting

SCREEN NASH T2D

Sponsor:

LMC Diabetes & Endocrinology Ltd.

Code:

NCT05029583

Conditions

Nonalcoholic Steatohepatitis

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

routine screening

physician-driven screening

Study Details

Brief summary:

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

Conditions

Nonalcoholic Steatohepatitis

Type 2 Diabetes

Study ID

NCT05029583

Start date

Aug 11, 2021

Status verified date

Jan, 2024

Completion date

Oct 5, 2025

Anticipated

Primary completion date

Oct 5, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: routine screening group

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

active comparator: physician-driven screening group

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

Interventions

routine screening

routine screening for advanced NASH

physician-driven screening

physician-driven screening for advanced NASH

Primary outcome measure

  • Prevalence of presumed advanced NASH based on biochemical and FibroScan results [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Lisa Chu, PhD

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

Locations

LMC Diabetes & Endocrinology Ltd.

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Contacts

Lisa Chu, PhD

lisa.chu@lmc.ca

Principal Investigator:

Harpreet Bajaj, MD

More Information

Sponsor

LMC Diabetes & Endocrinology Ltd.

Last update posted

Jan 24, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LMC Diabetes & Endocrinology Ltd. on 2024-01-24.