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A cohort study establishing a high-risk warning model for progressive hepatic fibrosis in metabolic-associated fatty liver disease (MASLD) among patients with type 2 diabetes and overweight or obesity

A cohort study establishing a high-risk warning model for progressive hepatic fibrosis in metabolic-associated fatty liver disease (MASLD) among patients with type 2 diabetes and overweight or obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127110
Enrollment
Unknown
Registered
2026-06-24
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

metabolic associated fatty liver disease

Interventions

Case series:none

Sponsors

the Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Definitive diagnosis of type 2 diabetes mellitus (meeting clinically accepted diagnostic criteria); 3. Baseline BMI >=24 kg/m², or being recorded as overweight/obese in outpatient records; 4. Imaging findings or clinical data supporting the presence of fatty liver disease or metabolic associated steatohepatosis (MASH); 5. Disposition of routine laboratory tests and physical measurements within 30 days prior to and following timepoint T0 (the outpatient evaluation point determining whether further liver fibrosis stratification testing is warranted); 6. Completion of at least one reference-standardized liver fibrosis assessment method (e.g., transient elastography or magnetic resonance elastography) within 180 days after timepoint T0.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of viral hepatitis, autoimmune liver disease, significant alcohol-related liver disease, or other known non-metabolic chronic liver diseases; 2. History of decompensated cirrhosis, hepatocellular carcinoma, or liver transplantation; 3. Pregnancy status, presence of active malignant tumors, or other severe systemic diseases significantly affecting liver function and metabolic status; 4. Lack of core baseline variables (e.g., waist circumference, HbA1c, AST, ALT) or inability to obtain reference standard outcomes (such as liver fibrosis assessment results).

Design outcomes

Primary

MeasureTime frame
FibroScan Controlled Attenuation Parameter (CAP);Liver Hardness Value (LSM);sensitivity;specificity;

Countries

China

Contacts

Public ContactQian Liao

Xinqiao Hospital, Shapingba District, Chongqing, China

1129755644@qq.com+86 23 6875 5079

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026