NCT01306110

Brief Summary

The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

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

June 1, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

3.5 years

First QC Date

February 28, 2011

Last Update Submit

January 7, 2016

Conditions

Diabetes

Keywords

Liver fibrosisdiabetesFibroscanFibrotestnoninvasive fibrosis biomarkers

Eligibility Criteria

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

Patients with diabetes

You may qualify if:

  • Male or female subjects
  • More than 18 years of age
  • Patients with Diabetes
  • Written informed consent

You may not qualify if:

  • Patients refusing to participate to the study and to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Hepato-Gastroentérologie Hopital Haut-Leveque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Diabetes MellitusLiver Cirrhosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Victor De Ledinghen, MD PhD

    University Hospital, Bordeaux

    STUDY DIRECTOR

  • Juliette Foucher, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Julien Vergniol, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Vincent Rigalleau, MD PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

June 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

FR(1)