Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

Official title:

Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997424
• Other study ID #: JWGUHMED1-007
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention

Device:
• Controlled Attenuation Parameter (CAP), Echosens, Paris, France

• FibroScan, Echosens, Paris, France

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steatosis	• 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%)	one day
Secondary	Fibrosis	• 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)	one day
Secondary	Steatosis (serum)	• Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus	one day