Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co ExistINSTInCTNCT03760172
Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
An observational study of Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial summary
NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis. Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist
- How many people
- 7,300 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2019to 31 Dec 2021
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all population
Who may be able to join
- NAFLD with biopsy proven disease above 18 years
- IMID patients above 18 years
- All participants must give informed written consent
Who cannot join
- Patients who had any clinical evidence of malignancy
- Other secondary cause of chronic liver disease. Alternative causes of liver disease included excessive alcohol intake (higher than 20 g/day in women and 30 g/day in men), viral hepatitis, chronic alcohol consumption, autoimmune hepatitis, Wilson´s disease, alpha-1-antitripsine deficiency, inborn errors of metabolism or drug induced liver injury
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Maria Teresa Arias Loste, MD, 942204089
About this study
NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis.
Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at least in a subset of patients, the development of NASH in the absence of classic metabolic risk factor.
Read more
Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes co-exist.
First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome ande second, a predominantly metabolic phenptype, strongly associated to he metabolic syndrome.
In this way, we believe that in a particular subset of NAFLD patients, NASH could be considered as an IMID, as most of the definiting features of IMIDs are present. To demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we will adress the molecular and immunophenotype characterization in liver biopsies of NASH patients with and without the co-existence of IMIDs.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prevalence of NAFLD in patients with IMID | To analyze the global prevalence of NAFLD in patients with an immune-mediated inflammatory disease IMID | |
| Prevalence of High-risk NASH in patients with IMID | To evaluate the prevalence of high-risk NASH (NASH with advanced fibrosis) in patients with IMID through clinical, radiological and histological evaluation | |
| Immunophenptypic characterization | To investigate the existence of common and differential immunophenotypes between the subjects with NASH with and without IMID, and patients with IMID without liver involment | |
| Genetic and Molecular characterization | Liver molecular characterization of NASH associated to IMID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD in patients with IMID
Prevalence of NAFLD in patients with IMID
Measured: January 2019 - December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start7 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co ExistStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 7,300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, Puerta de Hierro University Hospital
- Responsible party
- Principal investigator, MARIA CINTA ALMENARA MIRAMON, Instituto de Investigación Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760172
- Sponsor's protocol ID
- PI18/01304
- Acronym
- INSTInCT
- Status last verified
- Nov 2018
- First submitted
- 29 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
- ClinicalTrials.gov ID
- NCT03760172
- Acronym / sponsor ID
- INSTInCT / PI18/01304
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,300 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, Puerta de Hierro University Hospital
- Study start
- 7 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Nov 2018 (actual)
- 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.
NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis.
Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at least in a subset of patients, the development of NASH in the absence of classic metabolic risk factor.
Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes co-exist.
First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome ande second, a predominantly metabolic phenptype, strongly associated to he metabolic syndrome.
In this way, we believe that in a particular subset of NAFLD patients, NASH could be considered as an IMID, as most of the definiting features of IMIDs are present. To demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we will adress the molecular and immunophenotype characterization in liver biopsies of NASH patients with and without the co-existence of IMIDs.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prevalence of NAFLD in patients with IMID | – | –To analyze the global prevalence of NAFLD in patients with an immune-mediated inflammatory disease IMID |
| Prevalence of High-risk NASH in patients with IMID | – | –To evaluate the prevalence of high-risk NASH (NASH with advanced fibrosis) in patients with IMID through clinical, radiological and histological evaluation |
| Immunophenptypic characterization | – | –To investigate the existence of common and differential immunophenotypes between the subjects with NASH with and without IMID, and patients with IMID without liver involment |
| Genetic and Molecular characterization | – | –Liver molecular characterization of NASH associated to IMID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all population
Key inclusion criteria (3 listed)
- NAFLD with biopsy proven disease above 18 years
- IMID patients above 18 years
- All participants must give informed written consent
Key exclusion criteria (2 listed)
- Patients who had any clinical evidence of malignancy
- Other secondary cause of chronic liver disease. Alternative causes of liver disease included excessive alcohol intake (higher than 20 g/day in women and 30 g/day in men), viral hepatitis, chronic alcohol consumption, autoimmune hepatitis, Wilson´s disease, alpha-1-antitripsine deficiency, inborn errors of metabolism or drug induced liver injury
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
Prevalence of NAFLD in patients with IMID
Time frame: January 2019 - December 2020
Prevalence of NAFLD in patients with IMID
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
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.
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 Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
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 2 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 30 Nov 2018. 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 Spain. 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 Maria Teresa Arias Loste, MD (942202520, mteresa.arias@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD in patients with IMID (time frame: January 2019 - December 2020). 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 30 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.