Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

• Registration Number: NCT01997424
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Steatosis	one day	• Evaluating the presence of liver steatosis in patients with diabetes mellitus using the ultrasound-based method "Controlled Attenuation Parameter", which is integrated in the FibroScan machine and can non-invasively quantify liver steatosis (Steatosis fibrosis scores I-III \[ Designated as safety issue: No \]; Steatosis scores: 0 = \<5% I = 5-33% II = 33-66% III = \>66%)

Secondary Outcome Measures

Name	Time	Method
Fibrosis	one day	• Evaluation of the prevalence of liver fibrosis using transientelastography (FibroScan) and serological markers in patients with diabetes mellitus (Liver fibrosis scores I-IV (METAVIR) \[ Designated as safety issue: No \]; METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis)
Steatosis (serum)	one day	• Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany