Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
Type 2 Diabetes | Nonalcoholic SteatohepatitisThe study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 to 80
Participation 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)
Study Location
LMC Diabetes & Endocrinology Ltd.
LMC Diabetes & Endocrinology Ltd.Toronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- LMC Diabetes & Endocrinology Ltd.
- Participants Required
- More Information
- Study ID:
NCT05029583