NCT01997424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

6.7 years

First QC Date

October 23, 2013

Last Update Submit

February 1, 2021

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Fibrosis

    one day

  • Steatosis (serum)

    one day

Interventions

Controlled Attenuation Parameter (CAP), Echosens, Paris, FranceDEVICE
FibroScan, Echosens, Paris, FranceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years and older
  • Written informed consent
  • Diabetes mellitus type 1 or 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Mireen Friedrich-Rust, MD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 28, 2013

Study Start

May 1, 2013

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

DE(1)