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Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

NCT06364462 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-05-29

No results posted yet for this study

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.

Conditions

  • NASH
  • Liver Fibrosis

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.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Jidong Jia, Professor · Beijing Friendship Hospital

  • Jingmin Zhao, Professor · Beijing 302 Hospital

  • Jing Zhang · Beijing You-an Hospital, Capital Medical University

  • Minghui Li · Beijing Ditan Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2027-03-09
Completion
2027-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06364462 on ClinicalTrials.gov