Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Treatments: Device: FibroScan, Echosens, Paris, France; Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France

Study type: Interventional

Funder types: Other

Identifiers

NCT01997424

JWGUHMED1-007

Details and patient eligibility

About

This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination:

• Transient Elastography and Controlled Attenuation Parameter using the FibroScan
• blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.

Enrollment: 340 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years and older
• Written informed consent
• Diabetes mellitus type 1 or 2

Exclusion criteria

• Patients with mental diseases
• Pregnancy or lactation
• Ascites
• Continued alcohol consumption (> 21 drinks/week for male and > 14 drinks/week for female patients)
• Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson)
• Hepatocellular carcinoma/ Liver metastasis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)