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Completed

NCT Number: NCT01997424

Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

FibroScan, Echosens, Paris, France

Device

Primary outcomes

  1. Steatosis

    Time frame: 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 outcomes

  1. Fibrosis

    Time frame: 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)

  2. Steatosis (serum)

    Time frame: one day

    • Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2013
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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