Enhanced screening for liver disease in type 2 diabetes patients
A Cluster Randomized Trial to Determine Diagnostic and Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
This study tests different ways to screen for liver disease in adults with type 2 diabetes to see which method helps identify those at risk for NASH better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | LMC Diabetes & Endocrinology Ltd. Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05029583 on ClinicalTrials.gov |
What this trial studies
This study is a multi-centered, stratified cluster randomized controlled trial aimed at evaluating different screening strategies for Nonalcoholic Steatohepatitis (NASH) in adults with Type 2 Diabetes (T2D). Participants will be recruited from independent clinic sites and will undergo biochemical screening to identify those at risk for NASH. Depending on the clinic site, participants will receive either routine or physician-driven screening interventions. The study will also collect clinical data and assess health-related quality of life to understand the impact of the screening methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a clinical diagnosis of Type 2 Diabetes and specific body mass index or waist circumference criteria.
Not a fit: Patients with a known history of liver disease or significant alcohol consumption, as well as those with unstable health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of NASH in patients with Type 2 Diabetes, potentially reducing liver-related complications.
How similar studies have performed: Other studies have shown promise in using enhanced screening strategies for liver diseases, suggesting that this approach may yield beneficial outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Toronto, Ontario
- LMC Diabetes & Endocrinology Ltd. — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Harpreet Bajaj, MD — LMC Diabetes & Endocrinology Ltd.
- Study coordinator: Lisa Chu, PhD
- Email: lisa.chu@LMC.ca
- Phone: 416-268-8787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.