Risk FactorsMASLD RoNCT06864845
Risk of MASLD in Adults in Romania
An observational study of Risk Factors and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Internist.Ro at 2 sites in Romania.
Trial summary
This study aims to evaluate the presence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) risk factors and estimate the probability of advanced liver disease in a Romanian cohort from the European Health Examination Survey (EHES). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Factors, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- How many people
- 5,340 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Aug 2022to 31 Oct 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The EHES study aimed to enroll a representative sample of the adult population aged 25-64. Considering the structure of the Romanian population in this age group, a minimum sample size of 4235 enrollees was considered. Also, knowing from other European EHES studies that the enrollment rate was 50%, the pre study sample population selected from the lists of family doctors was 9600. Out of the total 9600, after excluding non-eligibles (893), refusals (2846) and incomplete evaluations (481), 5380 participants were included in the study.
Who may be able to join
- Age ≥18 years
- Participation in the EHES Romania study
Who cannot join
- Missing essential data preventing reliable MASLD and liver disease risk assessment:
- Missing biochemical data (ALT, GGT, platelets, cholesterol)
- Missing clinical and anthropometric data (age, weight and height)
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Transylvania University School of Medicine
Brasov, Brașov County, 500019
National Institute for Public Health
Bucharest, Bucharest, 050463
About this study
Official title: Evaluation of Risk Factors for MASLD and Probability of Advanced Liver Disease in a the Romanian Arm of the the European Health Examination Survey (EHES)
This study aims to evaluate the presence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) risk factors and estimate the probability of advanced liver disease in a Romanian cohort from the European Health Examination Survey (EHES). Using standardized clinical, anthropometric, and laboratory data, the study will assess metabolic and alcohol-related contributors to liver disease. The primary focus is to identify an at-risk MASLD population, characterize associated metabolic risk factors, and evaluate disease awareness through the presence of ICD-10 diagnostic codes for liver disease.
The study applies the Forns Score as a validated non-invasive tool for assessing liver fibrosis risk and incorporates the latest EASL-AASLD 2024 guidelines to define MASLD, MASH, Alcohol-Related Liver Disease (ALD), and MetALD (combined metabolic and alcohol-related liver disease). Additionally, it will explore potential underdiagnosis rates of liver disease by comparing clinical risk markers with documented diagnoses.
The study is a post hoc, cross-sectional, retrospective analysis and does not involve new data collection or patient contact. Data analysis will be performed using descriptive statistics, subgroup comparisons, and multivariate models to assess relationships between metabolic risk factors, MASLD probability, and liver disease awareness. This research will contribute to the understanding of MASLD epidemiology in Romania and inform public health strategies for early detection and prevention.
Read the detailed description
Detailed Description
This study is designed as a post hoc analysis of data from the European Health Examination Survey (EHES) - Romania, focusing on MASLD risk factors and advanced liver disease probability. The EHES is a large-scale population survey conducted in European countries, with standardized methodologies for data collection, ensuring comparability across different nations.
Study Objectives Primary Objective: Define an at-risk MASLD population in Romania.
Secondary Objectives:
Identify additional liver disease risk factors (viral hepatitis, iron overload, alcohol consumption).
Identify a population of confirmed advanced liver disease patients. Assess hepatitis prevalence vs. disease awareness (ICD-10 coding). Identify potential risk factors associated with hepatitis.
Study Design and Methodology Study Type: Observational, cross-sectional, retrospective. Data Source: EHES Romania dataset. Population: Adults (≥18 years) included in the EHES survey. Exclusion Criteria: Missing Forns Score variables (platelet count, total cholesterol, gamma-glutamyl transferase, age).
Sample Size Estimation: Based on MASLD prevalence (25-30%), minimum n=1000-1500 for subgroup analyses. (5300 available) Definition of Liver Disease Subtypes (EASL-AASLD 2024 Guidelines) MASLD: Hepatic steatosis with at least one metabolic risk factor. MASH: Progressive MASLD with hepatocellular injury and fibrosis. ALD: Liver disease in individuals exceeding alcohol thresholds (≥30g/day men, ≥20g/day women).
MetALD: Overlap of MASLD and ALD.
Statistical Analysis Plan Descriptive statistics for population characteristics and MASLD prevalence. Subgroup comparisons (MASLD vs. non-MASLD, ALD vs. non-ALD, etc.). Multivariate logistic regression for risk factor associations. Sensitivity analysis for missing data handling. Quality Assurance and Data Management EHES follows standardized data validation, quality control, and external audits.
Data checks and verification against medical records ensure accuracy. No new data collection or patient interaction in this study.
Ethical Considerations The EHES obtained informed consent from all participants [PMID: 39491016]. This study uses anonymized, pre-existing data. No ethical approval needed beyond EHES compliance. Data Sharing Statement Individual participant data will not be publicly available. Aggregated results will be shared upon request. Funding Statement No external funding. Study Timeline Data analysis starts: 20/02/2025 Expected completion:1/04/2025
- Keywords
- MASH, MASLD, risk, prevalence awareness
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 |
|---|---|---|
| MASLD-At-Risk Cohort | Individuals meeting MASLD criteria based on metabolic dysfunction risk factors and hepatic steatosis. | |
| MASH Cohort | Subgroup with MASLD who meet additional criteria for hepatic inflammation and fibrosis risk. | |
| Alcohol-Related Liver Disease (ALD) Cohort: | Participants exceeding alcohol consumption thresholds who exhibit liver dysfunction and no other risk factors for liver diseas | |
| MetALD Cohort: | Individuals exhibiting both MASLD and ALD characteristics, requiring combined metabolic and alcohol-related assessment and no other risk factors for liver disease | |
| Non-MASLD Control Group | Participants with no significant metabolic dysfunction and normal liver function and no other risk factors for liver disease serving as a reference population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors.
Classification for the composite outcome requires the presence of at least one of the following five cardiometabolic risk factors:
Overweight or Obesity: Defined by a Body Mass Index (BMI) ≥25 kg/m² for non-Asians and ≥23 kg/m² for Asians.
Type 2 Diabetes Mellitus: A confirmed diagnosis of type 2 diabetes. Insulin Resistance: Indicators include fasting glucose levels ≥100 mg/dL or HbA1c ≥5.7%.
Dyslipidemia: Characterized by triglycerides ≥150 mg/dL or reduced HDL cholesterol levels (<40 mg/dL for men and <50 mg/dL for women).
Hypertension: Blood pressure readings ≥130/85 mmHg or the use of antihypertensive medications.
Unit of Measure: Percentage of total study population.
Measured: Baseline
Secondary outcomes (3)
Identification of Patients with Known Liver Disease
Description: The proportion of individuals with known liver disease
Other known liver diseases will be accepted according to ICD-10:
B18.0, B18.1, B18.8, B18.9, K75.4, E83.0, K74.3, K83.01, D86.8, D86.9, M35.00, M35.09 , K74.60, K74.69, K70.30, K70.31, K74.0, K74.1, K74.2, K76.0, K75.81
Unit of Measure: Percentage of participants with known liver disease from the sample
Measured: Baseline
Identification of a Population with Probable Advanced Liver Disease:
Description: This outcome will estimate the prevalence of advanced liver disease using the Forns Score.
Assessment Methods:
The Forns Score will be applied to identify individuals at high risk of fibrosis.
FORNS calculation utilizes the following formula : [7.811 - 3.131 × ln [number of platelets] × 0.781 ln [GGTP (U/L)] + 3.467 × ln [age (years)] - 0.014 [cholesterol (mg/dL)]\].
Risk Classification:
Low Risk: Forns Score <4.2 (rules out significant fibrosis, ≥F2) High Risk: Forns Score >6.9 (indicates significant fibrosis, ≥F2)
Unit of Measure: Percentage of participants
Time Frame: Baseline
Measured: Baseline
Identification of Potential Factors Associated with advanced liver disease.
This outcome will analyze demographic, metabolic, and lifestyle variables associated with the presence of viral hepatitis.
Assessment Methods:
Multivariable logistic regression will be used to assess associations between hepatitis status and:
Demographics: Age, sex, socioeconomic status Metabolic risk factors: Obesity (BMI, WHR), diabetes (HbA1c, fasting glucose) Lifestyle: Smoking status, alcohol consumption, physical activity Outcome Measurement: Identification of significant predictors of hepatitis using adjusted odds ratios and confidence intervals.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Aug 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Risk FactorsStudies 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
- Cross-sectional
- Enrolment
- 5,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Internist.Ro
- Sponsor type
- University, hospital or other
- Collaborators
- Transilvania University of Brasov
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864845
- Sponsor's protocol ID
- A002
- Other IDs
- PDP1/NT2311/13.05.2020
- Acronym
- MASLD Ro
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brinduse LA, Eclemea I, Neculau AE, Paunescu BA, Bratu EC, Cucu MA. Rural versus urban healthcare through the lens of health behaviors and access to primary care: a post-hoc analysis of the Romanian health evaluation survey. BMC Health Serv Res. 2024 Nov 4;24(1):1341. doi: 10.1186/s12913-024-11861-9.
PubMed 39491016Forns X, Ampurdanes S, Llovet JM, Aponte J, Quinto L, Martinez-Bauer E, Bruguera M, Sanchez-Tapias JM, Rodes J. Identification of chronic hepatitis C patients without hepatic fibrosis by a simple predictive model. Hepatology. 2002 Oct;36(4 Pt 1):986-92. doi: 10.1053/jhep.2002.36128.
PubMed 12297848Pimpin L, Cortez-Pinto H, Negro F, Corbould E, Lazarus JV, Webber L, Sheron N; EASL HEPAHEALTH Steering Committee. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. J Hepatol. 2018 Sep;69(3):718-735. doi: 10.1016/j.jhep.2018.05.011. Epub 2018 May 17.
PubMed 29777749Peacock A, Leung J, Larney S, Colledge S, Hickman M, Rehm J, Giovino GA, West R, Hall W, Griffiths P, Ali R, Gowing L, Marsden J, Ferrari AJ, Grebely J, Farrell M, Degenhardt L. Global statistics on alcohol, tobacco and illicit drug use: 2017 status report. Addiction. 2018 Oct;113(10):1905-1926. doi: 10.1111/add.14234. Epub 2018 Jun 4.
PubMed 29749059Stival C, Lugo A, Odone A, van den Brandt PA, Fernandez E, Tigova O, Soriano JB, Jose Lopez M, Scaglioni S, Gallus S; TackSHS Project Investigators. Prevalence and Correlates of Overweight and Obesity in 12 European Countries in 2017-2018. Obes Facts. 2022;15(5):655-665. doi: 10.1159/000525792. Epub 2022 Aug 2.
PubMed 35917801Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9.
PubMed 30414863Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.
PubMed 28930295
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Risk Factors for MASLD and Probability of Advanced Liver Disease in a the Romanian Arm of the the European Health Examination Survey (EHES)
- ClinicalTrials.gov ID
- NCT06864845
- Acronym / sponsor ID
- MASLD Ro / A002
- Keywords
- MASH, MASLD, risk, prevalence awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,340 participants (actual)
- Lead sponsor
- Internist.RoUniversity, hospital or other
- Collaborators
- Transilvania University of Brasov
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 Mar 2025 (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.
This study aims to evaluate the presence of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) risk factors and estimate the probability of advanced liver disease in a Romanian cohort from the European Health Examination Survey (EHES). Using standardized clinical, anthropometric, and laboratory data, the study will assess metabolic and alcohol-related contributors to liver disease. The primary focus is to identify an at-risk MASLD population, characterize associated metabolic risk factors, and evaluate disease awareness through the presence of ICD-10 diagnostic codes for liver disease.
The study applies the Forns Score as a validated non-invasive tool for assessing liver fibrosis risk and incorporates the latest EASL-AASLD 2024 guidelines to define MASLD, MASH, Alcohol-Related Liver Disease (ALD), and MetALD (combined metabolic and alcohol-related liver disease). Additionally, it will explore potential underdiagnosis rates of liver disease by comparing clinical risk markers with documented diagnoses.
The study is a post hoc, cross-sectional, retrospective analysis and does not involve new data collection or patient contact. Data analysis will be performed using descriptive statistics, subgroup comparisons, and multivariate models to assess relationships between metabolic risk factors, MASLD probability, and liver disease awareness. This research will contribute to the understanding of MASLD epidemiology in Romania and inform public health strategies for early detection and prevention.
Detailed description
Detailed Description
This study is designed as a post hoc analysis of data from the European Health Examination Survey (EHES) - Romania, focusing on MASLD risk factors and advanced liver disease probability. The EHES is a large-scale population survey conducted in European countries, with standardized methodologies for data collection, ensuring comparability across different nations.
Study Objectives Primary Objective: Define an at-risk MASLD population in Romania.
Secondary Objectives:
Identify additional liver disease risk factors (viral hepatitis, iron overload, alcohol consumption).
Identify a population of confirmed advanced liver disease patients. Assess hepatitis prevalence vs. disease awareness (ICD-10 coding). Identify potential risk factors associated with hepatitis.
Study Design and Methodology Study Type: Observational, cross-sectional, retrospective. Data Source: EHES Romania dataset. Population: Adults (≥18 years) included in the EHES survey. Exclusion Criteria: Missing Forns Score variables (platelet count, total cholesterol, gamma-glutamyl transferase, age).
Sample Size Estimation: Based on MASLD prevalence (25-30%), minimum n=1000-1500 for subgroup analyses. (5300 available) Definition of Liver Disease Subtypes (EASL-AASLD 2024 Guidelines) MASLD: Hepatic steatosis with at least one metabolic risk factor. MASH: Progressive MASLD with hepatocellular injury and fibrosis. ALD: Liver disease in individuals exceeding alcohol thresholds (≥30g/day men, ≥20g/day women).
MetALD: Overlap of MASLD and ALD.
Statistical Analysis Plan Descriptive statistics for population characteristics and MASLD prevalence. Subgroup comparisons (MASLD vs. non-MASLD, ALD vs. non-ALD, etc.). Multivariate logistic regression for risk factor associations. Sensitivity analysis for missing data handling. Quality Assurance and Data Management EHES follows standardized data validation, quality control, and external audits.
Data checks and verification against medical records ensure accuracy. No new data collection or patient interaction in this study.
Ethical Considerations The EHES obtained informed consent from all participants [PMID: 39491016]. This study uses anonymized, pre-existing data. No ethical approval needed beyond EHES compliance. Data Sharing Statement Individual participant data will not be publicly available. Aggregated results will be shared upon request. Funding Statement No external funding. Study Timeline Data analysis starts: 20/02/2025 Expected completion:1/04/2025
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MASLD-At-Risk Cohort | – | –Individuals meeting MASLD criteria based on metabolic dysfunction risk factors and hepatic steatosis. |
| MASH Cohort | – | –Subgroup with MASLD who meet additional criteria for hepatic inflammation and fibrosis risk. |
| Alcohol-Related Liver Disease (ALD) Cohort: | – | –Participants exceeding alcohol consumption thresholds who exhibit liver dysfunction and no other risk factors for liver diseas |
| MetALD Cohort: | – | –Individuals exhibiting both MASLD and ALD characteristics, requiring combined metabolic and alcohol-related assessment and no other risk factors for liver disease |
| Non-MASLD Control Group | – | –Participants with no significant metabolic dysfunction and normal liver function and no other risk factors for liver disease serving as a reference population. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The EHES study aimed to enroll a representative sample of the adult population aged 25-64. Considering the structure of the Romanian population in this age group, a minimum sample size of 4235 enrollees was considered. Also, knowing from other European EHES studies that the enrollment rate was 50%, the pre study sample population selected from the lists of family doctors was 9600. Out of the total 9600, after excluding non-eligibles (893), refusals (2846) and incomplete evaluations (481), 5380 participants were included in the study.
Key inclusion criteria (2 listed)
- Age ≥18 years
- Participation in the EHES Romania study
Key exclusion criteria (3 listed)
- Missing biochemical data (ALT, GGT, platelets, cholesterol)
- Missing clinical and anthropometric data (age, weight and height)
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
Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors.
Time frame: Baseline
Classification for the composite outcome requires the presence of at least one of the following five cardiometabolic risk factors: Overweight or Obesity: Defined by a Body Mass Index (BMI) ≥25 kg/m² for non-Asians and ≥23 kg/m² for Asians. Type 2 Diabetes Mellitus: A confirmed diagnosis of type 2 diabetes. Insulin Resistance: Indicators include fasting glucose levels ≥100 mg/dL or HbA1c ≥5.7%. Dyslipidemia: Characterized by triglycerides ≥150 mg/dL or reduced HDL cholesterol levels (<40 mg/dL for men and <50 mg/dL for women). Hypertension: Blood pressure readings ≥130/85 mmHg or the use of antihypertensive medications. Unit of Measure: Percentage of total study population.
3 secondary outcomes
Identification of Patients with Known Liver Disease
Time frame: Baseline
Identification of a Population with Probable Advanced Liver Disease:
Time frame: Baseline
Identification of Potential Factors Associated with advanced liver disease.
Time frame: Baseline
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 12 Mar 2025.
- Results publication: PubMed 39491016Brinduse LA, Eclemea I, Neculau AE, Paunescu BA, Bratu EC, Cucu MA. Rural versus urban healthcare through the lens of health behaviors and access to primary care: a post-hoc analysis of the Romanian health evaluation survey. BMC Health Serv Res. 2024 Nov 4;24(1):1341. doi: 10.1186/s12913-024-11861-9.
- Results publication: PubMed 12297848Forns X, Ampurdanes S, Llovet JM, Aponte J, Quinto L, Martinez-Bauer E, Bruguera M, Sanchez-Tapias JM, Rodes J. Identification of chronic hepatitis C patients without hepatic fibrosis by a simple predictive model. Hepatology. 2002 Oct;36(4 Pt 1):986-92. doi: 10.1053/jhep.2002.36128.
- Results publication: PubMed 29777749Pimpin L, Cortez-Pinto H, Negro F, Corbould E, Lazarus JV, Webber L, Sheron N; EASL HEPAHEALTH Steering Committee. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. J Hepatol. 2018 Sep;69(3):718-735. doi: 10.1016/j.jhep.2018.05.011. Epub 2018 May 17.
- Results publication: PubMed 29749059Peacock A, Leung J, Larney S, Colledge S, Hickman M, Rehm J, Giovino GA, West R, Hall W, Griffiths P, Ali R, Gowing L, Marsden J, Ferrari AJ, Grebely J, Farrell M, Degenhardt L. Global statistics on alcohol, tobacco and illicit drug use: 2017 status report. Addiction. 2018 Oct;113(10):1905-1926. doi: 10.1111/add.14234. Epub 2018 Jun 4.
- Results publication: PubMed 35917801Stival C, Lugo A, Odone A, van den Brandt PA, Fernandez E, Tigova O, Soriano JB, Jose Lopez M, Scaglioni S, Gallus S; TackSHS Project Investigators. Prevalence and Correlates of Overweight and Obesity in 12 European Countries in 2017-2018. Obes Facts. 2022;15(5):655-665. doi: 10.1159/000525792. Epub 2022 Aug 2.
- Results publication: PubMed 30414863Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9.
- Results publication: PubMed 28930295Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Risk Factors and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Internist.Ro at 2 sites in Romania.
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 2 inclusion and 3 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 12 Mar 2025. 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 Romania. 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?
Definition of an at-risk for MASLD population in Romania based on metabolic and hepatic risk factors. (time frame: Baseline). 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 NCT06864845, which also lists 7 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 12 Mar 2025.