Non Alcoholic Fatty Liver DiseaseNCT02820285
Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH
A study testing Evaluation of the staging of fibrosis liver, Determine the expression level of semaphorin and Determination of the composition of immunity cells in people with Non Alcoholic Fatty Liver Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Evaluation of the staging of fibrosis liver, Determine the expression level of semaphorin and Determination of the composition of immunity cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Sep 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged 18-65 years
- Patients with body mass index justifying a surgery for obesity (BMI ≥ 40 kg / m2 or BMI ≥ 35 kg / m2 with comorbidities)
- Consumption of alcohol <20 g / d
- Patients affiliated to a social security insurance
- Patients who signed the informed consent
Who cannot join
- Hemochromatosis
- Toxic hepatitis
- Deficiency of alpha-1-antitrypsin
- Wilson's disease
- Liver Autoimmune disease (primary biliary cirrhosis, autoimmune hepatitis)
- Hepatitis B, C
Show all 11Show fewer
- Drug-induced hepatitis
- Presence of HIV status
- Corticosteroids, amiodarone, valproic acid, tamoxifen, anti-inflammatory drugs, lipid lowering agents, testosterone agonists or beta-adrenergic antagonists, orlistat.
- Pregnant or breastfeeding women
- Incarcerated patients or patient under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Hépato-Gastroentérologie - Hôpital de l'Archet
Nice, 06003
About this study
Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions.
The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- Evaluation of the staging of fibrosis liver, Determine the expression level of semaphorin, Determination of the composition of immunity cells
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the staging of fibrosis liverOther
The investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies
Determine the expression level of semaphorinOther
The investigators will determine the expression level (gene and protein) of immune semaphorin and their (s) receptor (s) in the liver and subcutaneous and visceral adipose tissue by RT-PCR,
Determination of the composition of immunity cellsOther
The investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting
)
| Study group | Role | What they receive |
|---|---|---|
| Morbid obese patients | Other | Not described Receives: Other: Evaluation of the staging of fibrosis liver; Other: Determine the expression level of semaphorin; Other: Determination of the composition of immunity cells |
| Control patients | Other | Not described Receives: Other: Evaluation of the staging of fibrosis liver; Other: Determine the expression level of semaphorin; Other: Determination of the composition of immunity cells |
| Patients with overweight, steatosis and steatohepatitis | Other | Not described Receives: Other: Evaluation of the staging of fibrosis liver; Other: Determine the expression level of semaphorin; Other: Determination of the composition of immunity cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the staging of liver fibrosis
The investigators determine the stage of liver fibrosis by histological study of biopsies
Measured: Day 0
Determination of the expression of level of semaphorin
The investigators determine by technic of Reverse Transcription Polymerase Chain Reaction (RT-PCR) the expression of level of semaphorin
Measured: Day 0
Determination of the composition of immunity cells
The investigators determine the composition of immunity cells by Immunohistochemical and biochemical analyses (Western Blotting)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startMar 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert TRAN, MDPhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820285
- Sponsor's protocol ID
- 11-PP-10
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2016
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Patouraux S, Rousseau D, Bonnafous S, Lebeaupin C, Luci C, Canivet CM, Schneck AS, Bertola A, Saint-Paul MC, Iannelli A, Gugenheim J, Anty R, Tran A, Bailly-Maitre B, Gual P. CD44 is a key player in non-alcoholic steatohepatitis. J Hepatol. 2017 Aug;67(2):328-338. doi: 10.1016/j.jhep.2017.03.003. Epub 2017 Mar 16.
PubMed 28323124Sans A, Bailly L, Anty R, Sielezenef I, Gugenheim J, Tran A, Gual P, Iannelli A. Baseline Anthropometric and Metabolic Parameters Correlate with Weight Loss in Women 1-Year After Laparoscopic Roux-En-Y Gastric Bypass. Obes Surg. 2017 Nov;27(11):2940-2949. doi: 10.1007/s11695-017-2720-8.
PubMed 28550439
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH
- ClinicalTrials.gov ID
- NCT02820285
- Acronym / sponsor ID
- 11-PP-10
- Conditions
- Non Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Jun 2016 (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.
Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions.
The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morbid obese patients | Other | Other: Evaluation of the staging of fibrosis liver, Other: Determine the expression level of semaphorin, Other: Determination of the composition of immunity cells |
| Control patients | Other | Other: Evaluation of the staging of fibrosis liver, Other: Determine the expression level of semaphorin, Other: Determination of the composition of immunity cells |
| Patients with overweight, steatosis and steatohepatitis | Other | Other: Evaluation of the staging of fibrosis liver, Other: Determine the expression level of semaphorin, Other: Determination of the composition of immunity cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged 18-65 years
- Patients with body mass index justifying a surgery for obesity (BMI ≥ 40 kg / m2 or BMI ≥ 35 kg / m2 with comorbidities)
- Consumption of alcohol <20 g / d
- Patients affiliated to a social security insurance
- Patients who signed the informed consent
Key exclusion criteria (11 listed)
- Hemochromatosis
- Toxic hepatitis
- Deficiency of alpha-1-antitrypsin
- Wilson's disease
- Liver Autoimmune disease (primary biliary cirrhosis, autoimmune hepatitis)
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 |
|---|---|---|
| Evaluation of the staging of fibrosis liverThe investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies | Other | Control patients, Morbid obese patients, Patients with overweight, steatosis and steatohepatitis |
| Determine the expression level of semaphorinThe investigators will determine the expression level (gene and protein) of immune semaphorin and their (s) receptor (s) in the liver and subcutaneous and visceral adipose tissue by RT-PCR, | Other | Control patients, Morbid obese patients, Patients with overweight, steatosis and steatohepatitis |
| Determination of the composition of immunity cellsThe investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting ) | Other | Control patients, Morbid obese patients, Patients with overweight, steatosis and steatohepatitis |
Primary outcome
Evaluation of the staging of liver fibrosis
Time frame: Day 0
The investigators determine the stage of liver fibrosis by histological study of biopsies
Determination of the expression of level of semaphorin
Time frame: Day 0
The investigators determine by technic of Reverse Transcription Polymerase Chain Reaction (RT-PCR) the expression of level of semaphorin
Determination of the composition of immunity cells
Time frame: Day 0
The investigators determine the composition of immunity cells by Immunohistochemical and biochemical analyses (Western Blotting)
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 31 Mar 2026.
- Results publication: PubMed 28323124Patouraux S, Rousseau D, Bonnafous S, Lebeaupin C, Luci C, Canivet CM, Schneck AS, Bertola A, Saint-Paul MC, Iannelli A, Gugenheim J, Anty R, Tran A, Bailly-Maitre B, Gual P. CD44 is a key player in non-alcoholic steatohepatitis. J Hepatol. 2017 Aug;67(2):328-338. doi: 10.1016/j.jhep.2017.03.003. Epub 2017 Mar 16.
- Derived from this study: PubMed 28550439Sans A, Bailly L, Anty R, Sielezenef I, Gugenheim J, Tran A, Gual P, Iannelli A. Baseline Anthropometric and Metabolic Parameters Correlate with Weight Loss in Women 1-Year After Laparoscopic Roux-En-Y Gastric Bypass. Obes Surg. 2017 Nov;27(11):2940-2949. doi: 10.1007/s11695-017-2720-8.
- Individual participant dataSharing planned: No
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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.
Albert TRAN, MDPhD 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 Evaluation of the staging of fibrosis liver, Determine the expression level of semaphorin and Determination of the composition of immunity cells in people with Non Alcoholic Fatty Liver Disease, 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 5 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: finished, as of the sponsor's last update on 31 Mar 2026. 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?
Evaluation of the staging of liver fibrosis (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820285, which also lists 2 linked publications.
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 31 Mar 2026.