Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Sponsor
Beijing Municipal Administration of Hospitals
Study ID
NCT06707129
Status
Recruiting
Apply to this trial

Conditions

  • Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • life-style — OTHER
    The patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes.

Study Details

Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.

Key Dates

First listed
Nov 27, 2024
Start date
Aug 1, 2024
Status verified
Nov 2024
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Case group
    After successful patient screening and enrollment, visits will be conducted every 6 months to collect the following information: Physical examination, accompanying diseases, hematology: blood routine, coagulation function, serology, imaging, body fat measurement, liver puncture information (if applicable). Lifestyle questionnaire: Dietary characteristics, sleep/wake time, daily sitting time, exercise duration, exercise mode. Health education and lifestyle intervention guidance should be provided to patients based on exercise mode. When adjusting lifestyle for at least 1 year and no more than 3 years, a second liver biopsy should be performed to evaluate liver histological changes.

Primary Outcome Measure

Reversal of NASH liver fibrosis [ Time Frame: 12 months ]

Central Contacts

Related Studies