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Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Primary Purpose

Non-alcoholic Fatty Liver Disease (NAFLD)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Controlled Attenuation Parameter (CAP), Echosens, Paris, France
FibroScan, Echosens, Paris, France
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Frankfurt

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2013
Last Updated
February 1, 2021
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01997424
Brief Title
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus
Official Title
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease (NAFLD)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Controlled Attenuation Parameter (CAP), Echosens, Paris, France
Intervention Type
Device
Intervention Name(s)
FibroScan, Echosens, Paris, France
Primary Outcome Measure Information:
Title
Steatosis
Description
• 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%)
Time Frame
one day
Secondary Outcome Measure Information:
Title
Fibrosis
Description
• 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)
Time Frame
one day
Title
Steatosis (serum)
Description
• Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireen Friedrich-Rust, MD
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

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