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

Launched by LMC DIABETES & ENDOCRINOLOGY LTD. · Aug 25, 2021

Keywords

ClinConnect Summary

The SCREEN NASH T2D clinical trial is investigating new ways to identify and manage a liver condition called Nonalcoholic Steatohepatitis (NASH) in adults who have Type 2 Diabetes (T2D). NASH is a serious liver disease that can lead to liver damage and other health issues. This study is looking for adults aged 18 to 80 who have T2D and are overweight or have a larger waist size. Participants will be selected from those who meet specific health criteria and will help researchers understand how better screening strategies can improve care for people with both conditions.

If you decide to join this study, you'll be contributing to important research that could help many others in the future. Participants will undergo various assessments, and while the study is still recruiting, it's essential to know that certain health conditions or past medical history may disqualify someone from participating. If you or someone you know is interested and meets the criteria, it could be a great opportunity to play a role in advancing treatment for NASH in individuals with Type 2 Diabetes.

Gender

ALL

Eligibility 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)