DiabetesDIABSCANNCT01306110
Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study
An observational study of Diabetes, run by Association HGE CHU Bordeaux Sud at 1 site in France.
Trial summary
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 277 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes
Who may be able to join
- Male or female subjects
- More than 18 years of age
- Patients with Diabetes
- Written informed consent
Who cannot join
- Patients refusing to participate to the study and to provide written informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service Hepato-Gastroentérologie Hopital Haut-Leveque
Pessac, 33604
About this study
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes.
Read the 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.
- Conditions
- Diabetes
- Keywords
- Liver fibrosis, diabetes, Fibroscan, Fibrotest, noninvasive fibrosis biomarkers
- Medical subject headings
- Diabetes Mellitus, Liver Cirrhosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association HGE CHU Bordeaux Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, de Ledinghen, Association HGE CHU Bordeaux Sud
- Investigators
- Victor De Ledinghen, MD PhD, Study director, University Hospital, BordeauxJuliette Foucher, MD, Principal investigator, University Hospital, BordeauxJulien Vergniol, MD, Principal investigator, University Hospital, BordeauxVincent Rigalleau, MD PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306110
- Sponsor's protocol ID
- FS02-062007
- Acronym
- DIABSCAN
- Status last verified
- Jan 2016
- First submitted
- 28 Feb 2011
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study
- ClinicalTrials.gov ID
- NCT01306110
- Acronym / sponsor ID
- DIABSCAN / FS02-062007
- Conditions
- Diabetes
- Keywords
- Liver fibrosis, diabetes, Fibroscan, Fibrotest, noninvasive fibrosis biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Association HGE CHU Bordeaux SudUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes
Key inclusion criteria (4 listed)
- Male or female subjects
- More than 18 years of age
- Patients with Diabetes
- Written informed consent
Key exclusion criteria (1 listed)
- Patients refusing to participate to the study and to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor De Ledinghen, MD PhD study director
University Hospital, Bordeaux
Juliette Foucher, MD principal investigator
University Hospital, Bordeaux
Julien Vergniol, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Association HGE CHU Bordeaux Sud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016; AzTrials last refreshed its copy on 5 Nov 2026.