Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997424

Enrollment

340

Registered

2013-11-28

Start date

2013-05-31

Completion date

2019-12-31

Last updated

2021-02-03

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 (NAFLD)

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.

Interventions

DEVICEControlled Attenuation Parameter (CAP), Echosens, Paris, France

DEVICEFibroScan, Echosens, Paris, France

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026