Metabolic SyndromeNCT00399932
Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance. In some patients, the disease can progress into steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic inflammation and variable and progressive… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to May 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with type 2 diabetes
Who may be able to join
- metabolic syndrome with 3 out of 5 criteria (ATP III definition)
Who cannot join
- alcohol intake > 20g/day (women), > 30g/day (men)
- chronic liver disease of other cause: viral hepatitis (HBV, HCV), Wilson's disease, haemochromatosis, alpha1 anti-trypsin deficiency, drug-induced, ...
- decompensated cirrhosis (Child-Pugh 3)
- body weight > 120 Kg
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
StLuc University Hospital
Brussels, 1200
Michel Hermans, M.D., Ph.D
About this study
Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance. In some patients, the disease can progress into steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and end-stage liver disease.
Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up.
Read more
To date, histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis. the procedure is however associated with significant complication in 0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo the liver.
The aim of the study is to evaluate, in a population of patients with the metabolic syndrome, whether non-invasive tests may identify those with hepatic fibrosis.
At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and elastography by MRI will be performed. Those tests will be repeated within 2 months.
A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography) tests are suggestive of hepatic fibrosis.
This study will allow to determine
- whether hepatic fibrosis may be detected by non-invasive means in patients with NAFLD/NASH.
- whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity
- whether the presence of fatty liver interfere with the results of the fibroscan and the elastography.
- whether there are metabolic factors associated with an increased risk of fibrosis in this population.
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, insulin resistance, NASH, hepatic fibrosis, Fibroscan, elastography by MRI
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Liver Cirrhosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2009
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Yves J Horsmans, M.D.,PhD, Study director, StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399932
- Sponsor's protocol ID
- ELASTO1
- Status last verified
- Sep 2009
- First submitted
- 14 Nov 2006
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00399932
- Acronym / sponsor ID
- ELASTO1
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, insulin resistance, NASH, hepatic fibrosis, Fibroscan, elastography by MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (estimated)
- First posted
- 15 Nov 2006 (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.
Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance. In some patients, the disease can progress into steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and end-stage liver disease.
Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up.
To date, histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis. the procedure is however associated with significant complication in 0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo the liver.
The aim of the study is to evaluate, in a population of patients with the metabolic syndrome, whether non-invasive tests may identify those with hepatic fibrosis.
At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and elastography by MRI will be performed. Those tests will be repeated within 2 months.
A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography) tests are suggestive of hepatic fibrosis.
This study will allow to determine
- whether hepatic fibrosis may be detected by non-invasive means in patients with NAFLD/NASH.
- whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity
- whether the presence of fatty liver interfere with the results of the fibroscan and the elastography.
- whether there are metabolic factors associated with an increased risk of fibrosis in this population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with type 2 diabetes
Key inclusion criteria (1 listed)
- metabolic syndrome with 3 out of 5 criteria (ATP III definition)
Key exclusion criteria (4 listed)
- alcohol intake > 20g/day (women), > 30g/day (men)
- chronic liver disease of other cause: viral hepatitis (HBV, HCV), Wilson's disease, haemochromatosis, alpha1 anti-trypsin deficiency, drug-induced, ...
- decompensated cirrhosis (Child-Pugh 3)
- body weight > 120 Kg
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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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.
Yves J Horsmans, M.D.,PhD study director
StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium
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 Metabolic Syndrome, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Sep 2009. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves J Horsmans, M.D.,Ph.D. (32 2 764 28 37, horsmans@gaen.ucl.ac.be), or a site near the patient. 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 18 Sep 2009.