Steatosis of LiverMASLDNCT07652892
Impact of Steatotic Liver Disease Associated With Metabolic Dysfunction (MASLD) on Frailty, Cognition, and Quality of Life. A Gender-sensitive Approach Towards a Comprehensive and Equitable Perspective.
An observational study of Steatosis of Liver, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
The goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Steatosis of Liver
- How many people
- 140 participants
- Where
- 2 sitesSpain
- Study dates
- 26 May 2026to 25 May 2028
- How long will I take part?
- 12 Months
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The degree of frailty will be compared between patients with MASLD and a cohort of individuals without liver disease. For this purpose, we have a historical cohort of 135 individuals without liver disease from primary care clinics whose frailty was assessed using the Fried frailty index. From this cohort, we will select participants by matching sex and age with the MASLD patients recruited for the present study.
Who may be able to join
- Patients will be included who are able to provide informed consent and actively participate in periodic assessments.
Who cannot join
- Risky alcohol consumption:
- > 30 g/day in men and > 20 g/day in women. AUDIT score: > 7 points in men, > 5 in women.
- Other liver diseases (viral hepatitis, autoimmune hepatitis, etc.).
- Advanced neurodegenerative diseases or severe psychiatric disorders.
- Severe comorbidities or treatments that, in the researchers' judgment, may affect frailty and quality of life more than metabolic syndrome and liver disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
German Soriano, Digestive Pathology MD contact
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08031
Eva Román, Digestive Pathology Nurse, 0034630818580, ERoman@santpau.cat
Elisabeth Pérez-Chust, Internal Medicine Nurse
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08031
Eva Román, Digestive Pathology Nurse, 0034-630818580, ERoman@santpau.cat
About this study
Official title: IIBSP-MAS-2025-133
The goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters.
- Conditions
- Steatosis of Liver
- Keywords
- A condition characterized by the accumulation of fat in the liver, which is closely linked to metabolic disorders and occurs with low or no alcohol consumption.
- Medical subject headings
- Fatty Liver
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 |
|---|---|---|
| Patients diagnosed with MASLD | Consecutive patients diagnosed with MASLD at any degree of fibrosis between the ages of 20 and 80 will be included. The main variable will be the degree of frailty assessed by the LFI and the Fried Index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Frailty Index (LFI) score
Change in Liver Frailty Index (LFI) score from baseline to follow-up. Higher values indicate worsening frailty, whereas lower values indicate improvement in frailty.
Measured: Baseline to Month 12
Fried Frailty Index
The Fried Frailty Index assesses frailty based on five components: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Higher scores indicate greater frailty. Positive change scores indicate worsening frailty, whereas negative change scores indicate improvement.
Measured: Baseline to Month 12
Secondary outcomes (8)
Association Between Frailty and Functional Performance Measures
Association between frailty status (LFI and Fried Frailty Index) and functional performance assessed by gait speed, Timed Up and Go test, handgrip strength, and balance.
Measured: Baseline to Month 12
Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers
Relationship between frailty status and circulating inflammatory, metabolic, and oxidative stress biomarkers.
Measured: Baseline to Month 12.
Association Between Frailty and Hormonal Parameters
Relationship between frailty status and hormonal parameters, including female-specific variables such as menstrual status, menopausal status, and hormone replacement therapy use.
Measured: Baseline to Month 12
Association Between Frailty and Body Composition
Relationship between frailty status and body composition parameters assessed by bioelectrical impedance analysis, including phase angle.
Measured: Baseline to Month 12
Association Between Frailty and Gut Microbiota Composition
Relationship between frailty status and fecal microbiota composition assessed by shotgun metagenomic sequencing.
Measured: Baseline to Month 12
Association Between Frailty and Cognitive Function, Quality of Life, and Self-Esteem
Relationship between frailty status and cognitive performance, quality of life, illness perception, and self-esteem assessed using validated questionnaires.
Measured: Baseline to Month 12
Association Between Frailty and Social Determinants of Health and Gender Roles
Relationship between frailty status and social determinants of health, health literacy, and gender-related factors.
Measured: Baseline to Month 12
Development of an Artificial Intelligence-Based Frailty Risk Prediction Model
Development and evaluation of a predictive model integrating clinical, functional, biochemical, hormonal, microbiota, cognitive, psychosocial, and gender-related variables to identify patients at increased risk of frailty progression over one year.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start26 May 2026 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatosis of LiverStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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 only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Roman, Principal investigator, Institut de Recerca IR Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652892
- Sponsor's protocol ID
- IIBSP-MAS-2025-133
- Acronym
- MASLD
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIBSP-MAS-2025-133
- ClinicalTrials.gov ID
- NCT07652892
- Acronym / sponsor ID
- MASLD / IIBSP-MAS-2025-133
- Conditions
- Steatosis of Liver
- Keywords
- A condition characterized by the accumulation of fat in the liver, which is closely linked to metabolic disorders and occurs with low or no alcohol consumption.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 26 May 2026 (estimated)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 17 Jun 2026 (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 goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with MASLD | – | –Consecutive patients diagnosed with MASLD at any degree of fibrosis between the ages of 20 and 80 will be included. The main variable will be the degree of frailty assessed by the LFI and the Fried Index. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The degree of frailty will be compared between patients with MASLD and a cohort of individuals without liver disease. For this purpose, we have a historical cohort of 135 individuals without liver disease from primary care clinics whose frailty was assessed using the Fried frailty index. From this cohort, we will select participants by matching sex and age with the MASLD patients recruited for the present study.
Key inclusion criteria (1 listed)
- Patients will be included who are able to provide informed consent and actively participate in periodic assessments.
Key exclusion criteria (5 listed)
- Risky alcohol consumption:
- > 30 g/day in men and > 20 g/day in women. AUDIT score: > 7 points in men, > 5 in women.
- Other liver diseases (viral hepatitis, autoimmune hepatitis, etc.).
- Advanced neurodegenerative diseases or severe psychiatric disorders.
- Severe comorbidities or treatments that, in the researchers' judgment, may affect frailty and quality of life more than metabolic syndrome and liver disease.
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
Change in Liver Frailty Index (LFI) score
Time frame: Baseline to Month 12
Change in Liver Frailty Index (LFI) score from baseline to follow-up. Higher values indicate worsening frailty, whereas lower values indicate improvement in frailty.
Fried Frailty Index
Time frame: Baseline to Month 12
The Fried Frailty Index assesses frailty based on five components: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Higher scores indicate greater frailty. Positive change scores indicate worsening frailty, whereas negative change scores indicate improvement.
8 secondary outcomes
Association Between Frailty and Functional Performance Measures
Time frame: Baseline to Month 12
Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers
Time frame: Baseline to Month 12.
Association Between Frailty and Hormonal Parameters
Time frame: Baseline to Month 12
Association Between Frailty and Body Composition
Time frame: Baseline to Month 12
Association Between Frailty and Gut Microbiota Composition
Time frame: Baseline to Month 12
Association Between Frailty and Cognitive Function, Quality of Life, and Self-Esteem
Time frame: Baseline to Month 12
Association Between Frailty and Social Determinants of Health and Gender Roles
Time frame: Baseline to Month 12
Development of an Artificial Intelligence-Based Frailty Risk Prediction Model
Time frame: Baseline to Month 12
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 17 Jun 2026.
Related trials for Steatosis of Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
German Soriano, Digestive Pathology MD contact
Eva Roman principal investigator
Institut de Recerca IR Sant Pau
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 Steatosis of Liver, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites 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 1 inclusion and 5 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 17 Jun 2026. 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 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 Eva Román, Digestive Pathology Nurse (0034630818580, ERoman@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Frailty Index (LFI) score (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. 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 17 Jun 2026.