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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
de Ledinghen, Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier:
NCT01306110
First received: February 28, 2011
Last updated: January 7, 2016
Last verified: January 2016
  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:

Enrollment: 277
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Service Hepato-Gastroentérologie Hopital Haut-Leveque
Pessac, France, 33604
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 Vergniol, MD University Hospital, Bordeaux
Principal Investigator: Vincent Rigalleau, MD PhD University Hospital, Bordeaux
  More Information

Responsible Party: de Ledinghen, Professor, Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier: NCT01306110     History of Changes
Other Study ID Numbers: FS02-062007 
Study First Received: February 28, 2011
Last Updated: January 7, 2016
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 July 27, 2016