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Disease characteristic, nutritional and exercise intervention study in different grades of MRI-PDFF diagnosed NAFLD

Disease characteristic, nutritional and exercise intervention study in different grades of MRI-PDFF diagnosed NAFLD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022744
Enrollment
Unknown
Registered
2019-04-24
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease

Interventions

Grade1 steatosis:nutritional and exercise intervention
Grade 2 steatosis:nutritional and exercise intervention
Grade 3 steatosis:nutritional and exercise intervention

Sponsors

Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The patients be diagnosed with NAFLD should meet both clinical diagnosis, pathological diagnosis, and imaging diagnosis): Clinical diagnosis: 1. No history of alcohol or the alcohol intakes < 140g/week (female < 70g/week) in the past. 2. There is not diseases history which could result in the fatty liver, including autoimmune liver disease, DILI, or viral hepatitis and other diseases; 3. Based on the protopathy, there are some non-specific clinical manifestation, such as weak, nausea, emesis, anorexia, hepatalgia, and hepatosplenomegaly; 4. Appear the MetS-related component, such as obesity, IGT, lipid metabolism disorder, high blood pressure, high blood viscosity, UA, and hyperinsulinemia; 5. Inexplainable increased levels of serum ALT, AST, and GGT over 6 months. Pathological diagnosis: Biopsy pathological diagnosis must accord with the pathological diagnosis standard of NAFLD, such as the liver cell parenchymal fat change, ballooning change, and diffuse mild inflammation of hepatic lobule. Imaging diagnosis: Abdominal hepatic ultrasonography must accord with the standard of diffusibility fatty liver: 1) Liver echo are stronger in near field than kidney and spleen, be the bright liver; 2) Liver echo becomes week or fade away in the far field; 3) abnormal internal pipeline structures of liver. The degree of steatosis will be graded according to the results of MRI-PDFF: 1) Grade 0 is defined with the thresholds between 0-6.4%; 2) Grade 1 is defined with the thresholds between 6.4%-17.4%; 3) Grade 2 is defined with the thresholds between 17.4%-22.1%; 4) Grade 3 is defined with the thresholds higher than 22.1%.

Exclusion criteria

Exclusion criteria: 1) With other liver diseases that could result in the fatty liver, including autoimmune liver disease, DILI, or viral hepatitis and other diseases; 2) With malignant tumor, and the infection of biliary tract. Exclude the subjects that have taken the medicines which could result in the disorder of the serum levels of ALT, AST, GGT recently; 3) With serious organic disease, such as heart disease and malignant tumor; 4) drunk for a long time in the past, and the alcohol intake in male >140g/week (female > 70g/week); 5) researchers consider do not suit for study; 6) Be not able to complete follow-up visit at regular intervals.

Design outcomes

Primary

MeasureTime frame
PDFF value;CAP value;serum lipids parameters;NAFLD associated gene polymorphisms;

Countries

China

Contacts

Public ContactXin Yongning

Qingdao Municipal Hospital

xinyongning@163.com+86 0532-82789463

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026