NCT05029583

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

4.2 years

First QC Date

August 19, 2021

Last Update Submit

January 23, 2024

Conditions

Nonalcoholic SteatohepatitisType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (9)

  • Proportion of study participants with presumed high grade fibrosis

    3 months

  • Proportion of study participants with presumed any NASH

    3 months

  • Proportion of study participants with presumed F2/F3 NASH

    3 months

  • Proportion of study participants with a fibrosis-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values

    1 day

  • Proportion of study participants with a fibrosis and/or steatosis (stages)

    1 day

  • +4 more secondary outcomes

Study Arms (2)

routine screening group

EXPERIMENTAL

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

Other: routine screening

physician-driven screening group

ACTIVE COMPARATOR

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

Other: physician-driven screening

Interventions

routine screeningOTHER

routine screening for advanced NASH

routine screening group
physician-driven screeningOTHER

physician-driven screening for advanced NASH

physician-driven screening group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Harpreet Bajaj, MD

    LMC Diabetes & Endocrinology Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Chu, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The care provider is masked to the primary outcome of the study, but not masked to the intervention.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 31, 2021

Study Start

August 11, 2021

Primary Completion

October 5, 2025

Study Completion

October 5, 2025

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)