Trials / Not Yet Recruiting
Not Yet RecruitingNCT06364462
Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (estimated)
- Sponsor
- Beijing Friendship Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-06-15
- Primary completion
- 2027-03-09
- Completion
- 2027-04-01
- First posted
- 2024-04-15
- Last updated
- 2024-05-29
Source: ClinicalTrials.gov record NCT06364462. Inclusion in this directory is not an endorsement.