SteatohepatitisNCT00886301
Fatty Liver and Ectopic Fat in Overweight and Obese Patients
A study testing liver biopsy in people with Steatohepatitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Steatohepatitis
- What is being tested?
- liver biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to 2 Oct 2014
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 25 and 40
- ALAT level superior to normal level even after 3 months of diet
- alcohol consumption < 20 g/j for women and < 30 g/j for men
Who cannot join
- HIV, hepatitis B virus, hepatitis C virus positive
- known hemochromatosis
- glycemia > 1.26 g/L or under anti-diabetic treatment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.
Read the detailed description
Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases.
The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.
Fatty liver and ectopic fat accumulation will be particularly assessed.
- Conditions
- Steatohepatitis
- Being tested
- liver biopsy
- Keywords
- overweight, obesity, steatohepatitis, ectopic fat
- Medical subject headings
- Fatty Liver, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver biopsyProcedure or surgery
liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | obese or overweight patients with fatty liver or ectopic fat Receives: Procedure: liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients.
Measured: at inclusion and at year 1
Secondary outcomes (1)
Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.
Measured: at year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMar 2010
- Primary completion2 Oct 2014
- Study completion2 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodolphe ANTY, Dr, Principal investigator, Hepatogastroentérology, CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886301
- Sponsor's protocol ID
- 08-PP-08
- Status last verified
- Nov 2023
- First submitted
- 20 Apr 2009
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Liver and Ectopic Fat in Overweight and Obese Patients
- ClinicalTrials.gov ID
- NCT00886301
- Acronym / sponsor ID
- 08-PP-08
- Conditions
- Steatohepatitis
- Keywords
- overweight, obesity, steatohepatitis, ectopic fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- 2 Oct 2014 (actual)
- Study completion
- 2 Oct 2014 (actual)
- First posted
- 22 Apr 2009 (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 the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.
Detailed description
Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases.
The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.
Fatty liver and ectopic fat accumulation will be particularly assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: liver biopsyobese or overweight patients with fatty liver or ectopic fat |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 25 and 40
- ALAT level superior to normal level even after 3 months of diet
- alcohol consumption < 20 g/j for women and < 30 g/j for men
Key exclusion criteria (3 listed)
- HIV, hepatitis B virus, hepatitis C virus positive
- known hemochromatosis
- glycemia > 1.26 g/L or under anti-diabetic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver biopsyliver biopsy | Procedure or surgery | 1 |
Primary outcome
Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients.
Time frame: at inclusion and at year 1
1 secondary outcome
Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.
Time frame: at year 1
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 13 Nov 2023.
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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.
Rodolphe ANTY, Dr principal investigator
Hepatogastroentérology, CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver biopsy in people with Steatohepatitis, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 3 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 13 Nov 2023. 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.
What does the primary outcome measure?
Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients. (time frame: at inclusion and at year 1). It is what the study was designed to measure, not a finding.
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 13 Nov 2023.