NAFLDNCT05554224
Integrated Multi-omics Data for Personalized Treatment of Obesity-associated Fatty Liver Disease
An observational study of NAFLD and Obesity, Morbid, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
The investigators seek to analyze the samples provided by patients with obesity-associated fatty liver disease at the multi-omics level and to integrate the results with clinical information, genotypic variants, and factors influencing inter-organ crosstalk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Obesity, Morbid, Comorbidities and Coexisting Conditions
- What is being tested?
- To propose diagnostic tests for liver diseases before surgical decisions.
- How many people
- 1,104 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jun 2008to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants are consecutive patients with obesity type II or III attending the bariatric surgery unit for treatment. In this center, women are more frequent than men. The average age is 49 (interquartile range 41 - 58). Steatohepatitis (~30 percent), type 2 diabetes mellitus (~40 percent), hypertension (~60 percent), and dyslipidemia (~35 percent) are the most prevalent comorbidities. Other common ailments are obstructive sleep apnea (~20 percent) and hypothyroidism (~10 percent).
Who may be able to join
- Body mass index greater or equal to 40 kg/m^2.
- Body mass index between 35 and 40 kg/m^2 with high-risk comorbidities (diagnosis or treatment for hypertension, dyslipidemia, or type 2 diabetes mellitus).
- Positive psychiatric evaluation.
- Age greater or equal to 18 years old.
Who cannot join
- Legal or illegal drug consumption, including alcohol.
- Diagnosis of Hepatitis.
- Current cancer diagnosis or treatment.
- Clinical or analytical evidence of severe illness.
- Clinical or analytical evidence of chronic or acute inflammation.
- Clinical or analytical evidence of infectious diseases.
- Clinical or analytical evidence of terminal illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Sant Joan
Reus, Tarragona, 43204
Jorge Joven, Professor, +34977310300 ext. 55409, jorge.joven@urv.cat
Jorge Joven, Professor
About this study
Official title: Integrated Multi-omics and Machine Learning-driven Personalized Treatment of Obesity-associated Fatty Liver Disease
The investigators seek to analyze the samples provided by patients with obesity-associated fatty liver disease at the multi-omics level and to integrate the results with clinical information, genotypic variants, and factors influencing inter-organ crosstalk. The main aim is to improve the interpretation of fatty liver disease associated with obesity and diabetes by developing predictive models built with algorithms from artificial intelligence. The challenge is to decipher the flow of information by exploring contributing factors, proximate causes of regulatory defects, and maladaptive responses that may promote therapeutic approaches.
Read the detailed description
The investigators study the most prevalent liver disease in the history of humankind, which is the leading cause of liver transplantation in its severe forms. It results from two silent pandemics with enormous health impacts: obesity and diabetes. Together or separately, they affect more than 30% of the world's population. The current term for the disease is MAFLD (metabolic (dysfunction)-associated fatty liver disease). This designation indicates that metabolic disorders related to obesity, diabetes, dyslipidemia, and hypertension are its primary cause. These disorders are related and lead to fat accumulation in the liver, the first step in a broad spectrum of chronic liver diseases. These diseases respond clinically in a very variable way and remain undiagnosed and untreated for a long time. There is no accepted pharmacological treatment, and lifestyle changes, although possibly effective, usually fail because they require particularly favorable conditions. Therefore, the identified problems that should be solve are:
(1) The diagnosis of MAFLD requires a liver biopsy, a costly and aggressive procedure. (2) Without examining the liver, clinicians can know little about the progression of the disease and the underlying causes. (3) The results in experimental models can be informative but difficult to translate to the clinic. Recent reports suggest the essential role of phospholipid biosynthesis and transport between the endoplasmic reticulum and mitochondria. (4) All of the above makes it difficult to obtain the necessary information to propose changes in clinical guidelines.
Considering these aspects, patients with morbid obesity can be an informative human model. Among other advantages, patients have surgical options that allow us to obtain portions of affected organs that facilitate specific diagnosis and that, because they require constant care, can be studied on an ongoing basis. The presented approach can improve patient care and essentially consists of identifying the most significant number of variables that can help. In particular, here are proposed the inclusion of variables that can already be obtained from recent advances in the laboratory, encompassed within the omics sciences (genomics, transcriptomics, proteomics, metabolomics, lipidomics, microbiomics). Each of these has its advantages and limitations. Predictive models can integrate these variables into clinical data to explore organ crosstalk.
- Being tested
- To propose diagnostic tests for liver diseases before surgical decisions.
- Keywords
- Weight loss, Bariatric surgery, Liver diseases, Mass spectrometry, Proteomics, Lipidomics, Metabolomics, Transcriptomics
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Morbid, Weight Loss, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To propose diagnostic tests for liver diseases before surgical decisions.Diagnostic test
Also called External follow up monitoring liver diseases and weight loss.
Observational although patients are candidates for metabolic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Severe obesity without liver disease | Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 0-2). Receives: Diagnostic Test: To propose diagnostic tests for liver diseases before surgical decisions. | |
| Severe obesity with liver disease without criteria for steatohepatitis | Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis, but their biopsies presented some liver severity (scores 3 and 4). Receives: Diagnostic Test: To propose diagnostic tests for liver diseases before surgical decisions. | |
| Severe obesity with well-defined steatohepatitis and/or cirrhosis | Patients with severe obesity who met the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 5-8). Receives: Diagnostic Test: To propose diagnostic tests for liver diseases before surgical decisions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
The effect of bariatric surgery on adiposity outcomes.
Measured: 1 to 10 years
Type 2 diabetes mellitus incidence
The effect of bariatric surgery on metabolic outcomes.
Measured: 1 to 10 years
Hypertension incidence
The effect of bariatric surgery on metabolic outcomes.
Measured: 1 to 10 years
Chronic liver diseases incidence
The usefulness of imaging techniques on metabolic outcomes.
Measured: 1 to 10 years
Dyslipidemia incidence
The effect of bariatric surgery on metabolic outcomes.
Measured: 1 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start25 Jun 2008
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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
- Prospective
- Enrolment
- 1,104 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Sant Joan, La Caixa Foundation, Instituto de Salud Carlos III, University of Barcelona
- Responsible party
- Principal investigator, Jorge Joven, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Jorge Joven, Professor, Principal investigator, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554224
- Sponsor's protocol ID
- EOM study
- Other IDs
- EPIMET
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2022
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2020 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity. Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R). The external collaborators, especially those involved in validation cohorts, may have access to data upon request. With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.
Publications
Jimenez-Franco A, Castane H, Martinez-Navidad C, Placed-Gallego C, Hernandez-Aguilera A, Fernandez-Arroyo S, Samarra I, Canela-Capdevila M, Arenas M, Zorzano A, Hernandez-Alvarez MI, Castillo DD, Paris M, Menendez JA, Camps J, Joven J. Metabolic adaptations in severe obesity: Insights from circulating oxylipins before and after weight loss. Clin Nutr. 2024 Jan;43(1):246-258. doi: 10.1016/j.clnu.2023.12.002. Epub 2023 Dec 6.
PubMed 38101315
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Multi-omics and Machine Learning-driven Personalized Treatment of Obesity-associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05554224
- Acronym / sponsor ID
- EOM study
- Keywords
- Weight loss, Bariatric surgery, Liver diseases, Mass spectrometry, Proteomics, Lipidomics, Metabolomics, Transcriptomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,104 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Hospital Universitari Sant Joan, La Caixa Foundation, Instituto de Salud Carlos III, University of Barcelona
- Study start
- 25 Jun 2008 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Sep 2022 (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.
The investigators seek to analyze the samples provided by patients with obesity-associated fatty liver disease at the multi-omics level and to integrate the results with clinical information, genotypic variants, and factors influencing inter-organ crosstalk. The main aim is to improve the interpretation of fatty liver disease associated with obesity and diabetes by developing predictive models built with algorithms from artificial intelligence. The challenge is to decipher the flow of information by exploring contributing factors, proximate causes of regulatory defects, and maladaptive responses that may promote therapeutic approaches.
Detailed description
The investigators study the most prevalent liver disease in the history of humankind, which is the leading cause of liver transplantation in its severe forms. It results from two silent pandemics with enormous health impacts: obesity and diabetes. Together or separately, they affect more than 30% of the world's population. The current term for the disease is MAFLD (metabolic (dysfunction)-associated fatty liver disease). This designation indicates that metabolic disorders related to obesity, diabetes, dyslipidemia, and hypertension are its primary cause. These disorders are related and lead to fat accumulation in the liver, the first step in a broad spectrum of chronic liver diseases. These diseases respond clinically in a very variable way and remain undiagnosed and untreated for a long time. There is no accepted pharmacological treatment, and lifestyle changes, although possibly effective, usually fail because they require particularly favorable conditions. Therefore, the identified problems that should be solve are:
(1) The diagnosis of MAFLD requires a liver biopsy, a costly and aggressive procedure. (2) Without examining the liver, clinicians can know little about the progression of the disease and the underlying causes. (3) The results in experimental models can be informative but difficult to translate to the clinic. Recent reports suggest the essential role of phospholipid biosynthesis and transport between the endoplasmic reticulum and mitochondria. (4) All of the above makes it difficult to obtain the necessary information to propose changes in clinical guidelines.
Considering these aspects, patients with morbid obesity can be an informative human model. Among other advantages, patients have surgical options that allow us to obtain portions of affected organs that facilitate specific diagnosis and that, because they require constant care, can be studied on an ongoing basis. The presented approach can improve patient care and essentially consists of identifying the most significant number of variables that can help. In particular, here are proposed the inclusion of variables that can already be obtained from recent advances in the laboratory, encompassed within the omics sciences (genomics, transcriptomics, proteomics, metabolomics, lipidomics, microbiomics). Each of these has its advantages and limitations. Predictive models can integrate these variables into clinical data to explore organ crosstalk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe obesity without liver disease | – | Diagnostic Test: To propose diagnostic tests for liver diseases before surgical decisions.Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 0-2). |
| Severe obesity with liver disease without criteria for steatohepatitis | – | Diagnostic Test: To propose diagnostic tests for liver diseases before surgical decisions.Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis, but their biopsies presented some liver severity (scores 3 and 4). |
| Severe obesity with well-defined steatohepatitis and/or cirrhosis | – | Diagnostic Test: To propose diagnostic tests for liver diseases before surgical decisions.Patients with severe obesity who met the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 5-8). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are consecutive patients with obesity type II or III attending the bariatric surgery unit for treatment. In this center, women are more frequent than men. The average age is 49 (interquartile range 41 - 58). Steatohepatitis (~30 percent), type 2 diabetes mellitus (~40 percent), hypertension (~60 percent), and dyslipidemia (~35 percent) are the most prevalent comorbidities. Other common ailments are obstructive sleep apnea (~20 percent) and hypothyroidism (~10 percent).
Key inclusion criteria (4 listed)
- Body mass index greater or equal to 40 kg/m^2.
- Body mass index between 35 and 40 kg/m^2 with high-risk comorbidities (diagnosis or treatment for hypertension, dyslipidemia, or type 2 diabetes mellitus).
- Positive psychiatric evaluation.
- Age greater or equal to 18 years old.
Key exclusion criteria (7 listed)
- Legal or illegal drug consumption, including alcohol.
- Diagnosis of Hepatitis.
- Current cancer diagnosis or treatment.
- Clinical or analytical evidence of severe illness.
- Clinical or analytical evidence of chronic or acute inflammation.
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 |
|---|---|---|
| To propose diagnostic tests for liver diseases before surgical decisions.Also: External follow up monitoring liver diseases and weight loss.Observational although patients are candidates for metabolic surgery. | Diagnostic test | Severe obesity with liver disease without criteria for steatohepatitis, Severe obesity with well-defined steatohepatitis and/or cirrhosis, Severe obesity without liver disease |
Primary outcome
Weight change
Time frame: 1 to 10 years
The effect of bariatric surgery on adiposity outcomes.
Type 2 diabetes mellitus incidence
Time frame: 1 to 10 years
The effect of bariatric surgery on metabolic outcomes.
Hypertension incidence
Time frame: 1 to 10 years
The effect of bariatric surgery on metabolic outcomes.
Chronic liver diseases incidence
Time frame: 1 to 10 years
The usefulness of imaging techniques on metabolic outcomes.
Dyslipidemia incidence
Time frame: 1 to 10 years
The effect of bariatric surgery on metabolic outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Derived from this study: PubMed 38101315Jimenez-Franco A, Castane H, Martinez-Navidad C, Placed-Gallego C, Hernandez-Aguilera A, Fernandez-Arroyo S, Samarra I, Canela-Capdevila M, Arenas M, Zorzano A, Hernandez-Alvarez MI, Castillo DD, Paris M, Menendez JA, Camps J, Joven J. Metabolic adaptations in severe obesity: Insights from circulating oxylipins before and after weight loss. Clin Nutr. 2024 Jan;43(1):246-258. doi: 10.1016/j.clnu.2023.12.002. Epub 2023 Dec 6.
- Individual participant dataSharing planned: Yes. The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2020 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity. Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R). The external collaborators, especially those involved in validation cohorts, may have access to data upon request. With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.
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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.
Jorge Joven, Professor principal investigator
Institut Investigacio Sanitaria Pere Virgili
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 NAFLD and Obesity, Morbid, run by Institut Investigacio Sanitaria Pere Virgili 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Joven, Professor (+34977310300 ext. 55409, jorge.joven@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 1 to 10 years). The study lists 5 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 NCT05554224, which also lists 1 linked publication.
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 13 Nov 2024.