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

Diabetes Clinical Trial

— DIABSCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306110
• Other study ID #: FS02-062007
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: January 7, 2016
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: Association HGE CHU Bordeaux Sud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
France	Service Hepato-Gastroentérologie Hopital Haut-Leveque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Association HGE CHU Bordeaux Sud

Country where clinical trial is conducted

France,