Nonalcoholic SteatohepatitisNCT05029583
Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
A study testing routine screening and physician-driven screening in people with Nonalcoholic Steatohepatitis and Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial summary
The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Type 2 Diabetes
- What is being tested?
- routine screening and physician-driven screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 11 Aug 2021to 5 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, M4G 3E8
Lisa Chu, PhD, lisa.chu@lmc.ca
Harpreet Bajaj, MD
About this study
Official title: A Cluster Randomized Trial to Determine Diagnostic and Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.
Read the detailed 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.
- Conditions
- Nonalcoholic Steatohepatitis, Type 2 Diabetes
- Being tested
- routine screening, physician-driven screening
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine screeningOther
routine screening for advanced NASH
physician-driven screeningOther
physician-driven screening for advanced NASH
| Study group | Role | What they receive |
|---|---|---|
| routine screening group | Experimental | consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2) Receives: Other: routine screening |
| physician-driven screening group | Active comparator | consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1) Receives: Other: physician-driven screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 1 day
Alcohol consumption by study arm - drinks per day
Alcohol consumption measured as self-reported average drinks per day
Measured: 1 day
Alcohol consumption by study arm - drinks per week
Alcohol consumption measured as self-reported average drinks per week
Measured: 1 day
Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score
Alcohol consumption measured with the Alcohol Use Disorders Identification Test (AUDIT). AUDIT scores range from a minimum score of 0 to a maximum score of 40, with higher scores indicating a worse outcome.
Measured: 1 day
Health-related quality of life by study arm
Health-related quality of life determined by the chronic liver disease questionnaire for non-alcoholic steatohepatitis (CLDQ-NASH) calculated as total CLDQ-NASH score. The CLDQ-NASH instrument includes 36 items grouped into six domains: abdominal symptoms; activity/energy; emotional health; fatigue; systemic symptoms; and worry. The average of the domain scores (min: 1, max: 7) yields the total CLDQ-NASH score. The minimum possible total score is 1 and the maximum possible total score is 7, with a higher total score indicating a better outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start11 Aug 2021
- Primary completion5 Oct 2025 (estimated)
- Study completion5 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harpreet Bajaj, MD, Principal investigator, LMC Diabetes & Endocrinology Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029583
- Sponsor's protocol ID
- SCREEN NASH T2D
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial to Determine Diagnostic and Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
- ClinicalTrials.gov ID
- NCT05029583
- Acronym / sponsor ID
- SCREEN NASH T2D
- Conditions
- Nonalcoholic Steatohepatitis, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 5 Oct 2025 (estimated)
- Study completion
- 5 Oct 2025 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine screening group | Experimental | Other: routine screeningconsists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2) |
| physician-driven screening group | Active comparator | Other: physician-driven screeningconsists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine screeningroutine screening for advanced NASH | Other | routine screening group |
| physician-driven screeningphysician-driven screening for advanced NASH | Other | physician-driven screening group |
Primary outcome
Prevalence of presumed advanced NASH based on biochemical and FibroScan results
Time frame: 3 months
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.
9 secondary outcomes
Proportion of study participants with presumed high grade fibrosis
Time frame: 3 months
Proportion of study participants with presumed any NASH
Time frame: 3 months
Proportion of study participants with presumed F2/F3 NASH
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
Time frame: 1 day
Proportion of study participants with a fibrosis and/or steatosis (stages)
Time frame: 1 day
Alcohol consumption by study arm - drinks per day
Time frame: 1 day
Alcohol consumption by study arm - drinks per week
Time frame: 1 day
Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score
Time frame: 1 day
Health-related quality of life by study arm
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harpreet Bajaj, MD principal investigator
LMC Diabetes & Endocrinology Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine screening and physician-driven screening in people with Nonalcoholic Steatohepatitis and Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Chu, PhD (416-268-8787, lisa.chu@LMC.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of presumed advanced NASH based on biochemical and FibroScan results (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.