Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

November 23, 2024 updated by: Minghui Li, Beijing Municipal Administration of Hospitals

Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • Recruiting
        • Beijing Ditan Hospital, Capital Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened

Description

Inclusion Criteria:

  • Aged between 18 and 70 years at the time of liver biopsy;
  • Gender is not limited;
  • Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
  • Signed written informed consent.

Exclusion Criteria:

  • Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
  • Women during pregnancy;
  • There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
  • Patients considered by the investigator to be unsuitable for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: life-style
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reversal of NASH liver fibrosis
Time Frame: 12 months
Reversal of NASH liver fibrosis based on liver biopsy definition
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in LSM value
Time Frame: 12 months
Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing
12 months
Changes in liver fat content
Time Frame: 12 months
Instantaneous liver elasticity detection of changes in liver fat content (CAP value)
12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time Frame: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10^9/L)×100
12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time Frame: 12 months

The dynamic changes of existing non-invasive evaluation models for fibrosis include:

FIB-4: Age, AST, ALT, platelets
12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time Frame: 12 months

The dynamic changes of existing non-invasive evaluation models for fibrosis include:

BARD：BMI ≥28, AST/ALT ≥0.8, diabetes
12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time Frame: 12 months

The dynamic changes of existing non-invasive evaluation models for fibrosis include:

NAFLD Fibrosis Score
12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time Frame: 12 months

The dynamic changes of existing non-invasive evaluation models for fibrosis include:

FAST
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including BMI;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including body fat percentage;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including blood pressure;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including sugar;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including glycated hemoglobin;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including fasting insulin;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including uric acid;
12 months
Dynamic changes in metabolic indicators of NAFLD
Time Frame: 12 months
Dynamic changes in metabolic indicators of NAFLD, including blood lipid series;
12 months
The occurrence of cirrhosis
Time Frame: 12 months
The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up.
12 months
The occurrence of liver outcome events
Time Frame: 12 months
The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths/liver transplantation.
12 months
Extrahepatic related events
Time Frame: 12 months
Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Municipal Administration of Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 23, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZLRK202301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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