Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

NCT ID: NCT01997424

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease (NAFLD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

FibroScan, Echosens, Paris, France

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Georg Dultz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mireen Friedrich-Rust, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

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University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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JWGUHMED1-007

Identifier Type: -

Identifier Source: org_study_id

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