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Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)

Type 2 Diabetes | Nonalcoholic Steatohepatitis

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

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Participation Requirements

  • 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

Primary Contact

Lisa Chu, PhD

[email protected]
Study Sponsored By
LMC Diabetes & Endocrinology Ltd.
Participants Required
More Information
Study ID: NCT05029583