Liver DiseaseNCT00844779
Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients
An observational study of Liver Disease, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Disease
- What is being tested?
- Bariatric surgery and cholecystectomy or benign liver tumor removal
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2009to Jan 2011
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor
- Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology).
- Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).
Who cannot join
- viral or autoimmune hepatitis
- hematochromatosis
- alcohol consumption (> 20 g/24h women, >30 g/24h men)
- type 1 diabetes
- inflammation or infection before procedure
- abnormal hemostasis or coagulation- pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil
Strasbourg, 67091
Michel DOFFOEL, MD, (33) 3 69 55 04 82, michel.doffoel@chru-strasbourg.fr
François HABERSETZER, MD
- Recruiting
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67091
Michel VIX, MD, (33) 3 69 55 10 52, michel.vix@chru-strasbourg.fr
Michel VIX, MD
About this study
Official title: Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches
Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. The diagnosis of these two entities is achieved by histology and neither imaging nor biochemical markers are accurate enough to discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis. Therefore, it is important to distinguish between HS and NASH in order to treat the patients accordingly. In this study, the investigators aim to understand the molecular mechanisms that govern the transition from benign steatosis to complicated NASH. The investigators will analyze by "Q-RT-PCR" and "DNA microarray" technologies in the liver of obese patients, the expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and identify the potential signaling pathways responsible for the progression of the disease.
- Conditions
- Liver Disease
- Being tested
- Bariatric surgery, cholecystectomy or benign liver tumor removal
- Keywords
- Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression, Non alcoholic fatty liver disease (NFALD)
- Medical subject headings
- Liver Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Gastric bypass.
cholecystectomy or benign liver tumor removalProcedure or surgery
cholecystectomy or benign liver tumor removal
| Study group | Role | What they receive |
|---|---|---|
| T | (n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor. Receives: Procedure: cholecystectomy or benign liver tumor removal | |
| A | (n=30): with central adiposity, insulin resistance and hepatic steatosis (histology). Receives: Procedure: Bariatric surgery | |
| B | (n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology). Receives: Procedure: Bariatric surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Michel DOFFOEL, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844779
- Sponsor's protocol ID
- 3966
- Status last verified
- Apr 2009
- First submitted
- 13 Feb 2009
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches
- ClinicalTrials.gov ID
- NCT00844779
- Acronym / sponsor ID
- 3966
- Conditions
- Liver Disease
- Keywords
- Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression, Non alcoholic fatty liver disease (NFALD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 16 Feb 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.
Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. The diagnosis of these two entities is achieved by histology and neither imaging nor biochemical markers are accurate enough to discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis. Therefore, it is important to distinguish between HS and NASH in order to treat the patients accordingly. In this study, the investigators aim to understand the molecular mechanisms that govern the transition from benign steatosis to complicated NASH. The investigators will analyze by "Q-RT-PCR" and "DNA microarray" technologies in the liver of obese patients, the expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and identify the potential signaling pathways responsible for the progression of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T | – | Procedure: cholecystectomy or benign liver tumor removal(n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor. |
| A | – | Procedure: Bariatric surgery(n=30): with central adiposity, insulin resistance and hepatic steatosis (histology). |
| B | – | Procedure: Bariatric surgery(n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor
- Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology).
- Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).
Key exclusion criteria (6 listed)
- viral or autoimmune hepatitis
- hematochromatosis
- alcohol consumption (> 20 g/24h women, >30 g/24h men)
- type 1 diabetes
- inflammation or infection before procedure
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 |
|---|---|---|
| Bariatric surgeryGastric bypass. | Procedure or surgery | A, B |
| cholecystectomy or benign liver tumor removalcholecystectomy or benign liver tumor removal | Procedure or surgery | T |
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 27 Apr 2009.
Related trials for Liver Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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.
Michel DOFFOEL, MD principal investigator
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease, run by University Hospital, Strasbourg, France at 2 sites 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 6 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 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Nassim DALI YOUCEF, PHD ((33) 3.69.55.11.84, ahmed.nassim.dali.youcef@chru-strasbourg.fr), 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 27 Apr 2009.