Nonalcoholic Steatohepatitis, Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
OTHERroutine screening
routine screening for advanced NASH
OTHERphysician-driven screening
physician-driven screening for advanced NASH
Sponsors
LMC Diabetes & Endocrinology Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Masking description
The care provider is masked to the primary outcome of the study, but not masked to the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of presumed advanced NASH based on biochemical and FibroScan results | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of study participants with presumed any NASH | 3 months | 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) |
| Proportion of study participants with presumed F2/F3 NASH | 3 months | 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) |
| 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-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values (FIB-4 ≥1.3 or/and NFS \>-1.455) |
| Proportion of study participants with a fibrosis and/or steatosis (stages) | 1 day | Proportion of study participants with a fibrosis and/or steatosis (stages) based on FibroScan results |
| Proportion of study participants with presumed high grade fibrosis | 3 months | 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) |
| Alcohol consumption by study arm - drinks per week | 1 day | Alcohol consumption measured as self-reported average drinks per week |
| Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score | 1 day | 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. |
| Health-related quality of life by study arm | 1 day | 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. |
| Alcohol consumption by study arm - drinks per day | 1 day | Alcohol consumption measured as self-reported average drinks per day |
Countries
Canada
Contacts
Primary ContactLisa Chu, PhD
Outcome results
None listed