Screening for Liver Fibrosis by Using Non-invasive Method... | NCT01306110

Studies
Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

NCT01306110

Sponsor

Association HGE CHU Bordeaux Sud

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

277Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Feb 28, 2011

First Submission Date that Met QC Criteria

Feb 28, 2011

First Posted Date

Mar 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Patients with diabetes are at risk for nonalcoholic fatty liver disease (NAFLD) leading to advanced fibrosis, cirrhosis, and liver cancer. However, liver fibrosis screening in this large population needs non-invasive methods. Recently, FibroScan was shown to be a good method for the diagnosis of advanced fibrosis in NAFLD patients. We examined the efficacy of a screening strategy with a noninvasive fibrosis biomarker (FibroTest) and transient elastography (FibroScan) in patients with diabetes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

277Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Hepato-Gastroentérologie Hopital Haut-Leveque		Pessac		33604	France

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided