NCT00575133

Brief Summary

To assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will be analyzed prospectively from a liver tissue bank.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Dec 2007Nov 2027

First Submitted

Initial submission to the registry

November 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
19.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Expected
Last Updated

February 24, 2012

Status Verified

February 1, 2012

First QC Date

November 26, 2007

Last Update Submit

February 23, 2012

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Disease regression/progression

    20 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-alcoholic fatty liver disease

You may qualify if:

  • Patients with histologically confirmed fatty liver disease

You may not qualify if:

  • History of significant alcohol consumption
  • Viral hepatitis
  • Autoimmune hepatitis
  • Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
  • Hepatotoxic medication (e.g. amiodarone).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Endocrinology and Diabetology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Giatgen Spinas, Prof. MD

    University Hospital Zurich, Endocrinology and Diabetology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Tschopp

CONTACT

+41 (0)44 255 11 11oliver.tschopp@usz.ch

Giatgen Spinas, Professor, MD

CONTACT

giatgen.spinas@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2007

First Posted

December 18, 2007

Study Start

December 1, 2007

Study Completion (Estimated)

November 1, 2027

Last Updated

February 24, 2012

Record last verified: 2012-02

Locations

CH(1)