Morbid ObesityNCT00914446
Identification of Protective and Worsening Steatohepatitis (NASH) Factors
A study testing hepatic biopsies in people with Morbid Obesity and Steatohepatitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepatitis or steatosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Steatohepatitis, Steatosis
- What is being tested?
- hepatic biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Apr 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects of the 2 sexes of 18-60 years old
- Patients with normal body mass index between 20-25 kg/m2
- Patients profiting from hepatectomy for benign tumors like adenoma or bulky tumor hepatic biliary cyst or from a repair of the abdominal wall
- Subjects affiliated to a mode of social security
- Patient having signed the enlightened consent
- The private subjects from freedom and the major subjects under supervision will be excluded
Show all 12Show fewer
- Subjects of the 2 sexes of 18-60 years old
- Patients with body mass index > 25 kg/m2
- Alcohol Consumption < 20 g/j
- Patient having a NASH in the hepatic biopsy
- Subjects affiliated to a mode of social security
- Patient having signed the enlightened consent
Who cannot join
- Hepatitis B, C, HIV
- Pregnant or breast-feeding woman.
- Inability to sign informed consent
- Patient with regulatory authority patient gold private freedom
- Hémochromatosis
- Toxic Hepatitis
Show all 11Show fewer
- Alpha-1-anti-trypsin Deficiency
- Wilson disease
- Auto-immune hepatitis
- Drug Hepatitis
- Orlistat
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nice Hôpital de l'Archet
Nice, NICE, 06003
ALBERT TRAN, Ph D, + 33 4 92 03 59 43, tran.a@chu-nice.fr
ALBERT TRAN, Ph D
About this study
Official title: Identification of Protective and Worsening Steatohepatitis (NASH) Factors by Microarray in Morbid Obesity Patients
The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepatitis or steatosis.
Read the detailed description
Recent epidemiological studies in France showed a strong prevalence of obesity (12,4%) and its strong increase during the 20 last years. Among the multiple complications related to obesity, the hepatic complications (steatosis and steatohepatitis (NASH)) are among most frequent. Our recent work showed that the adipose tissue, following the example of hepatic tissue also expressed CRP, the hepcidin and the IL-6 on a gene and protein level. We also noticed that 5% of our patients in spite of their obesity presented a normal liver without steatosis.
The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate the obese subjects having a normal liver from those with steatohepatitis or steatosis. The gene studies will be carried out initially in morbid obese subjects without diabetes (women, index of body mass > 40 kg/m2). We will select a sample of 10 patients having a normal liver, 10 patients having a NASH and 10 patients having a simple steatosis. These gene studies will be carried out in the liver and visceral adipose tissue from these same patients which will make possible to evaluate the interrelationship between the liver and the adipose tissue. We will also include 10 patients having an overweight and a NASH (study only on liver biopsy). The livers controls (10) will be provided from the department of surgery of Pr Jean Gugenheim and are practically all available. They are "healthy" tissue near hepatic benign tumors. Commercial ARN (Biosciences, Stratagene) will be also used. After identification of these profiles of gene expression in a restricted number of patients, we will validate these profiles of gene expression in a more significant number of patients (30 to 45 patients having a NASH compared with 30 to 45 patients having a simple steatosis).
The secondary objectives will be:
To compare the profile of gene expression between the liver and the adipose visceral and subcutaneous tissue from the morbid obese subjects After the identification of a group of genes of interest whose expression is modified in a small number of patients having a NASH, we continue our study with a more restricted number of genes.
- To validate in a more significant number of patients the modifications of expression of these genes by an approach by real-time PCR
- To determine the site of expression of these factors in the liver or adipose tissue by immunohistochemic analysis
- To determine the rate of expression of these factors in the liver or adipose tissue by biochemical analysis (Western blot)
- A serum dosage could finally be carried out to determine if the serum proteins could constitute a predictive index of the NASH or steatosis.
We will use the series of obese patients from the CHU of Nice whose a surgical approach of obesity was programmed. Preoperative explorations include clinico-biological assessments. During the intervention, the liver and adipose tissue biopsies will be systematically realized for research. We will also use the hepatic biopsies carried out among patients having an overweight and a NASH.
The feasibility of the work does not pose any problem. The department of surgery carries out 10 surgeries of obesity per month. We already have a series of 280 patients. We must include 150 patients in order to be able to obtain sufficiently patients with normal liver. For the other patients, we will use the tissue bank which is already carried out and the patients already gave the consent. Finally we must constitute a liver tissue bank for patients having an overweight. All these fundamental techniques are controlled within team from INSERM U 568 Awaited results: We could by this strategy select protective and worsening factors of steatohepatitis (NASH) which will be able to lead to identify predictive biological markers of the lesions of steatohepatitis and thus to identify patients at risk for the hepatic lesions. These factors could also serve as future therapeutic targets.
- Conditions
- Morbid Obesity, Steatohepatitis, Steatosis
- Being tested
- hepatic biopsies
- Keywords
- Steatohepatitis
- Medical subject headings
- Obesity, Morbid, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic biopsiesProcedure or surgery
hepatic biopsies
| Study group | Role | What they receive |
|---|---|---|
| morbid obese subject | Other | Not described Receives: Procedure: hepatic biopsies |
| overweight and NASH subjects | Other | Not described Receives: Procedure: hepatic biopsies |
| control subjects | Other | Not described Receives: Procedure: hepatic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomopathologic study of the hepatic biopsies.
Measured: one day
Secondary outcomes (5)
Seek protective and worsening factors by "microarray"
Measured: one day
Quantitative analyses of genes of interest in the liver and and visceral adipose tissue
Measured: one day
Immunohistochemical analyses
Measured: one day
Biochemical analyses
Measured: one day
Serum dosage of protein of interest
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionDec 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Investigators
- ALBERT TRAN, Ph D, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914446
- Sponsor's protocol ID
- 07-APR-05
- Status last verified
- Jun 2009
- First submitted
- 15 Apr 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Protective and Worsening Steatohepatitis (NASH) Factors by Microarray in Morbid Obesity Patients
- ClinicalTrials.gov ID
- NCT00914446
- Acronym / sponsor ID
- 07-APR-05
- Conditions
- Morbid Obesity, Steatohepatitis, Steatosis
- Keywords
- Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 5 Jun 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 main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepatitis or steatosis.
Detailed description
Recent epidemiological studies in France showed a strong prevalence of obesity (12,4%) and its strong increase during the 20 last years. Among the multiple complications related to obesity, the hepatic complications (steatosis and steatohepatitis (NASH)) are among most frequent. Our recent work showed that the adipose tissue, following the example of hepatic tissue also expressed CRP, the hepcidin and the IL-6 on a gene and protein level. We also noticed that 5% of our patients in spite of their obesity presented a normal liver without steatosis.
The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate the obese subjects having a normal liver from those with steatohepatitis or steatosis. The gene studies will be carried out initially in morbid obese subjects without diabetes (women, index of body mass > 40 kg/m2). We will select a sample of 10 patients having a normal liver, 10 patients having a NASH and 10 patients having a simple steatosis. These gene studies will be carried out in the liver and visceral adipose tissue from these same patients which will make possible to evaluate the interrelationship between the liver and the adipose tissue. We will also include 10 patients having an overweight and a NASH (study only on liver biopsy). The livers controls (10) will be provided from the department of surgery of Pr Jean Gugenheim and are practically all available. They are "healthy" tissue near hepatic benign tumors. Commercial ARN (Biosciences, Stratagene) will be also used. After identification of these profiles of gene expression in a restricted number of patients, we will validate these profiles of gene expression in a more significant number of patients (30 to 45 patients having a NASH compared with 30 to 45 patients having a simple steatosis).
The secondary objectives will be:
To compare the profile of gene expression between the liver and the adipose visceral and subcutaneous tissue from the morbid obese subjects After the identification of a group of genes of interest whose expression is modified in a small number of patients having a NASH, we continue our study with a more restricted number of genes.
- To validate in a more significant number of patients the modifications of expression of these genes by an approach by real-time PCR
- To determine the site of expression of these factors in the liver or adipose tissue by immunohistochemic analysis
- To determine the rate of expression of these factors in the liver or adipose tissue by biochemical analysis (Western blot)
- A serum dosage could finally be carried out to determine if the serum proteins could constitute a predictive index of the NASH or steatosis.
We will use the series of obese patients from the CHU of Nice whose a surgical approach of obesity was programmed. Preoperative explorations include clinico-biological assessments. During the intervention, the liver and adipose tissue biopsies will be systematically realized for research. We will also use the hepatic biopsies carried out among patients having an overweight and a NASH.
The feasibility of the work does not pose any problem. The department of surgery carries out 10 surgeries of obesity per month. We already have a series of 280 patients. We must include 150 patients in order to be able to obtain sufficiently patients with normal liver. For the other patients, we will use the tissue bank which is already carried out and the patients already gave the consent. Finally we must constitute a liver tissue bank for patients having an overweight. All these fundamental techniques are controlled within team from INSERM U 568 Awaited results: We could by this strategy select protective and worsening factors of steatohepatitis (NASH) which will be able to lead to identify predictive biological markers of the lesions of steatohepatitis and thus to identify patients at risk for the hepatic lesions. These factors could also serve as future therapeutic targets.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| morbid obese subject | Other | Procedure: hepatic biopsies |
| overweight and NASH subjects | Other | Procedure: hepatic biopsies |
| control subjects | Other | Procedure: hepatic biopsies |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects of the 2 sexes of 18-60 years old
- Patients with normal body mass index between 20-25 kg/m2
- Patients profiting from hepatectomy for benign tumors like adenoma or bulky tumor hepatic biliary cyst or from a repair of the abdominal wall
- Subjects affiliated to a mode of social security
- Patient having signed the enlightened consent
Key exclusion criteria (11 listed)
- Hepatitis B, C, HIV
- Pregnant or breast-feeding woman.
- Inability to sign informed consent
- Patient with regulatory authority patient gold private freedom
- Hémochromatosis
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 |
|---|---|---|
| hepatic biopsieshepatic biopsies | Procedure or surgery | control subjects, morbid obese subject, overweight and NASH subjects |
Primary outcome
Anatomopathologic study of the hepatic biopsies.
Time frame: one day
5 secondary outcomes
Seek protective and worsening factors by "microarray"
Time frame: one day
Quantitative analyses of genes of interest in the liver and and visceral adipose tissue
Time frame: one day
Immunohistochemical analyses
Time frame: one day
Biochemical analyses
Time frame: one day
Serum dosage of protein of interest
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
ALBERT TRAN, Ph D principal investigator
Centre Hospitalier Universitaire 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 hepatic biopsies in people with Morbid Obesity and 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 12 inclusion and 11 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 5 Jun 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 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 ALBERT TRAN, Ph D (+33 4 92 03 59 43, tran.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomopathologic study of the hepatic biopsies. (time frame: one day). 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 5 Jun 2009.