Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06364462

Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.

Official title: Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2024-06-15

Completion Date

2027-04-01

Last Updated

2024-05-29

Healthy Volunteers

No

Interventions

OTHER

lifestyle intervention

Dietary recommendations should consider energy restriction and exclusion of MAFLD-mediating components (processed food, food and beverages high in added fructose). A Mediterranean type diet is advisable. Both aerobic exercise and resistance training effectively reduce liver fat and should be tailored based on patient preferences to ensure long-term adherence.