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

This study is currently recruiting participants.
Verified June 2012 by Association HGE CHU Bordeaux Sud
Sponsor:
Information provided by:
Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier:
NCT01306110
First received: February 28, 2011
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

Resource links provided by NLM:


Further study details as provided by Association HGE CHU Bordeaux Sud:

Estimated Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diabetes

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306110

Locations
France
Service Hepato-Gastroentérologie Hopital Haut-Leveque Recruiting
Pessac, France, 33604
Contact: Victor de Ledinghen, MD, PhD    0033557656439    victor.deledinghen@chu-bordeaux.fr   
Contact: Sandrine Villars, PhD    33-557-656-311    sandrine.villars@chu-bordeaux.fr   
Sponsors and Collaborators
Association HGE CHU Bordeaux Sud
Investigators
Study Director: Victor De Ledinghen, MD PhD University Hospital, Bordeaux
Principal Investigator: Juliette Foucher, MD University Hospital, Bordeaux
Principal Investigator: Julien Vergnol, MD University Hospital, Bordeaux
Principal Investigator: Vincent Rigalleau, MD PhD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: Pr Victor De Ledinghen,MD PhD, CHU de Bordeaux
ClinicalTrials.gov Identifier: NCT01306110     History of Changes
Other Study ID Numbers: FS02-062007
Study First Received: February 28, 2011
Last Updated: June 20, 2012
Health Authority: France: Ministry of Health

Keywords provided by Association HGE CHU Bordeaux Sud:
Liver fibrosis
diabetes
Fibroscan
Fibrotest
noninvasive fibrosis biomarkers

Additional relevant MeSH terms:
Diabetes Mellitus
Fibrosis
Liver Cirrhosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014