Non-alcoholic Fatty Liver Disease (NAFLD)NASH-PINCT06688149
NASH Patient's Itinerary: Comparison of Strategies for Screening, Referring and Management of Diabetic Patients
A study testing Derivation algorithms in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 4 sites in 3 countries.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent, underdiagnosed, health system burden and impacts on quality of life including comorbidities in the affected population. Cost-effective strategies focusing on clinical pathways to detect and refer patients to care are needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Derivation algorithms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 Jan 2021to 8 Jan 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75.
- Type 2 Diabetes Mellitus. Patients will be considered as diabetic when: A1C ≥6.5% OR FPG ≥126 mg/dL OR 2-h PG ≥200 mg/dl during the OGTT OR anti-diabetic drug users.
Who cannot join
- Significant alcohol intake (>30 g daily for men and >20g daily for women).
- Evidence of concomitant liver disease (i.e., viral or autoimmune hepatitis, HIV, drug-induced fatty liver, hemochromatosis, or Wilson's disease).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
University Hospital Düsseldorf
Düsseldorf
University Medical Center Mainz
Mainz
About this study
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent, underdiagnosed, health system burden and impacts on quality of life including comorbidities in the affected population. Cost-effective strategies focusing on clinical pathways to detect and refer patients to care are needed. The aim of this study is to build a stepwise algorithm combining non-invasive freely available methods (FIB-4, NFS, HFS alone or combined) and vibration-controlled transient elastography (VCTE) in diabetic patients from primary care and endocrinology units.
Read the detailed description
NAFLD is a growing health concern and liver fibrosis severity determines its prognosis. The burden of this disease has been estimated in a quarter of the European population and is even higher in diabetic patients, where it raises significantly and can reach up to 80%. The fact that only 10% of these patients will develop significant fibrosis, the strongest predictor of liver-specific morbidity and overall mortality, leads to an overwhelming situation in primary care and endocrine units, where physicians need to screen large numbers of patients to identify individuals with a high risk for developing fibrosis that should be derived to a specialized hepatology unit. New free and accurate non- invasive tests need to be available to be used in primary care and non-hepatologists units to fight against this disappointing situation.
Several non-invasive methods, based on serum and imaging biomarkers, have aimed to identify at-risk patients for NAFLD-related fibrosis, but inconclusive results and many phenotypes that are present or not in patients (diabetes mellitus, obesity and age) reduce their diagnostic accuracy. Current strategies to monitor fibrosis are, therefore, inefficient and often fail to easily distinguish patients with mild disease that can be monitored at primary care from those at risk of advanced fibrosis or cirrhosis that need to receive specialised care and that could benefit from therapeutic interventions, such as participation in clinical trials and liver cancer surveillance programs.
The majority of patients with NAFLD are followed up in the community by general practitioners without definite diagnosis, representing a challenge to identify patients at risk of significant fibrosis who might benefit from an early specific intervention. Accurate fibrosis assessment by primary care or non-hepatologists physicians is limited by a reliance on liver function tests, which correlate poorly with fibrosis, and limited access to discriminatory fibrosis tests. Thus, current management strategies are inefficient in identifying subjects for specialist referral. Patients with mild disease are often referred for NAFLD specialist review when instead the appropriate preventative interventions of lifestyle changes can be delivered effectively in primary care. Conversely, patients with advanced fibrosis or cirrhosis who will benefit from NAFLD specific interventions, including clinical trials and cirrhosis surveillance, often remain undetected until they present with complications of cirrhosis, including hepatocellular carcinoma. This ineffective management contributes to the poor outcomes associated with liver disease and the increasing trends in NAFLD- related morbidity and mortality.
NASH-PI aims to improve the management of NAFLD patients by non-hepatologist physicians through the development of a new specific stepwise NAFLD algorithm following an ETC (Education, tools and communication) process that will be based on:
- The development of new care pathways based on different combinations of non-invasive tests that facilitate the derivation of diabetic patients from endocrine and primary care units to specialised liver disease units.
- Peer-to-peer sessions with primary care physicians and diabetologists to discuss the techniques and methods available to screen and detect diabetic patients at risk of developing NAFLD-related significant fibrosis.
- The implementation of easy and ready to use tools, like an automatic calculation of fNITs in central labs, to allow non-hepatologist physicians detect more efficiently diabetic patients at risk of significant fibrosis.
This proposal will focus on diabetic patients to test the feasibility and accuracy of these diagnostic strategies in a close circuit from primary care and diabetic clinics to NAFLD specialized Units (NSU). Our main goal is to create a NAFLD continuum of care that improves the selection of patients with fibrosis and cirrhosis for referral to secondary care, reducing unnecessary referrals, enhancing the use of healthcare resources with immediate cost-savings, and improving patient experiences by avoiding unnecessary clinic appointments and tests. NASH-PI will improve the identification of NAFLD in diabetic patients to allow for management according to current standard of care and impact on the disease course, helping to reduce NAFLD-related morbidity and mortality and delivering more efficient patient-centered care.
- Being tested
- Derivation algorithms
- Keywords
- NAFLD, MASLD, NASH, MASH, FIBROSIS, NITs, TRANSIENT ELASTOGRAPHY, FIB4, NFS, HFS, DIABETES
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Derivation algorithmsDiagnostic test
Derivation algorithm based on non-invasive methods, to standardise the continuum of care for diabetic patients with NAFLD from primary care and endocrinology settings to NAFLD specialised units (NSU)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Current management of NAFLD patients in daily clinical practice | Experimental | It will be taken as a reference for comparisons and will include the diagnosis and referral criteria that have been used the two previous years. CONSTANTS, a study included in the EPOS European Project has already allowed us to approach the burden of this entity in clinical practice in two sites of this consortium (Mainz and Sevilla). An overall analysis will be conducted to harmonize current standard of care (Arm A) in our centres. The case records of all patients referred with a diagnosis of NAFLD will be reviewed and evaluated for evidence of advanced fibrosis/cirrhosis based on a composite of history, physical examination, imaging, transient elastography, and liver histology when available. HFS, NFS, and FIB-4 scores will be calculated, and patients with a priori low-risk of advanced fibrosis will be deemed to have no evidence of liver fibrosis and thus referred inappropriately. Receives: Diagnostic Test: Derivation algorithms |
| Arm B: Combination of blood-based non-invasive tests (HFS, NFS, and FIB-4) | Experimental | Patients will be assigned with the following scores:
1. 0 points if the value is under the lower cut-off (HFS <0.12; NFS<-1.455; FIB-4 <1.30);
2. 1 point if the value is allocated in the grey zone (HFS 0.12-0.47; NFS -1.455-0.676; FIB-4 1.30-2.67);
3. 2 points if the value is above the higher cut-off (HFS >0.47; NFS >0.676; FIB-4 >2.67). We will determine the optimal cut-offs (between 0 and 6 points) for keeping patients in non-specialized units or referring them to NSUs.
* Age corrected threshold should be implemented in patients older than 65 years in NFS (from -1.455 to 0.12) and FIB-4 (from 1.30 to 2.00). Receives: Diagnostic Test: Derivation algorithms |
| Arm C: Combination of HFS and TE | Experimental | Patients will be classified using the blood-based non-invasive tests to determine the HFS and a transient Elastography (TE). Patients with a HFS score of > 0.12 or TE >8 kPa for both M and XL probe should be classified as patients with an intermediate-to-high risk of advanced fibrosis and will be referred to a specialist. Receives: Diagnostic Test: Derivation algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy on referral rate
To determine the accuracy on referral rate for diabetic patients at risk of advanced fibrosis using each of the strategies under study, and determine the sensitivity, specificity, PPV, NPV, likelihood ratios and overall accuracy of each of them.
Measured: Up to 6 months
Secondary outcomes (7)
Cut-off scores for fibrosis non-invasive tests (fNITs)
To define the best cut-off scores for fibrosis non-invasive tests (fNITs) when all these non-invasive tests are combined between them. Combined fibrosis score is a composite score including the results from FIF4, HFS and NFS, and ranges from 0 (no risk of fibrosis) and 3 (all 3 tests are altered and therefore patients have from more than 90% of risk of fibrosis).
Measured: 3 months
Cut-off score for Hepamet Fibrosis Score (HFS) + Transient Elastography (TE)
To define the best cut-off score for the Hepamet Fibrosis Score (HFS) when combined with Transient Elastography (TE). HFS higher that 0.12 indicates high risk of liver fibrosis, and TE higher that 8 KPa indicates risk of significant liver fibrosis.
Measured: 3 months
Evaluation of quality-adjusted life years (QALYs)
QALY scores will compare the benefits of the 3 different strategies/arms. QALY = Life Years Gained × Quality of Life Score. Quality of Life Score will be calculated by the Short-Form Six-Dimension (SF-6D) questionnaire, and ranges from 1 (perfect health) to 0 (death).
Measured: 9 months
Evaluation of Incremental Cost-Effectiveness Ratios (ICERs)
ICER will assess the cost per additional unit of health benefit achieved with each of the 3 strategies under study, calculated as euros per QALYs gained.
Measured: 9 months
Patient reported diet habits
To assess patient reported diet habits by the PREDIMED questionnaire, a validated 14-item questionnaire of Mediterranean diet adherence. Score lower than 9 means low adherence to Mediterranean diet, and score equal or higher than 9 means good adherence to Mediterranean diet
Measured: 6 months
Patient reported physical activity
To assess patient reported physical activity using the International Physical Activity Questionnaire (IPAQ) questionnaire. IPAQ classifies individuals into three categories based on their total Metabolic Equivalent of Task (MET) minutes per week. Low physical activity: Less than 600 MET-minutes/week; moderate physical activity: Between 600 and 3,000 MET-minutes/week; or high physical activity: More than 3,000 MET-minutes/week.
Measured: 6 months
Patient reported individual functioning
To assess patient reported individual functioning by the Short-Form Six-Dimension (SF-6D) questionnaire. Scores Closer to 1 indicate better health-related quality of life. Scores Closer to 0 reflect more severe health problems and limitations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start31 Jan 2021
- Primary completion31 Jan 2023
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Barcelona Institute for Global Health, Harokopio University, University Medical Center Mainz, University Düsseldorf
- Responsible party
- Sponsor
- Investigators
- Manuel Romero-Gómez, Principal investigator, Hospital Universitario Virgen del Rocío de Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688149
- Sponsor's protocol ID
- NASH-PI
- Acronym
- NASH-PI
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NASH Patient's Itinerary: Comparison of Strategies for Screening, Referring and Management of Diabetic Patients
- ClinicalTrials.gov ID
- NCT06688149
- Acronym / sponsor ID
- NASH-PI / NASH-PI
- Keywords
- NAFLD, MASLD, NASH, MASH, FIBROSIS, NITs, TRANSIENT ELASTOGRAPHY, FIB4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Gilead Sciences, Barcelona Institute for Global Health, Harokopio University, University Medical Center Mainz, University Düsseldorf
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 14 Nov 2024 (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.
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent, underdiagnosed, health system burden and impacts on quality of life including comorbidities in the affected population. Cost-effective strategies focusing on clinical pathways to detect and refer patients to care are needed. The aim of this study is to build a stepwise algorithm combining non-invasive freely available methods (FIB-4, NFS, HFS alone or combined) and vibration-controlled transient elastography (VCTE) in diabetic patients from primary care and endocrinology units.
Detailed description
NAFLD is a growing health concern and liver fibrosis severity determines its prognosis. The burden of this disease has been estimated in a quarter of the European population and is even higher in diabetic patients, where it raises significantly and can reach up to 80%. The fact that only 10% of these patients will develop significant fibrosis, the strongest predictor of liver-specific morbidity and overall mortality, leads to an overwhelming situation in primary care and endocrine units, where physicians need to screen large numbers of patients to identify individuals with a high risk for developing fibrosis that should be derived to a specialized hepatology unit. New free and accurate non- invasive tests need to be available to be used in primary care and non-hepatologists units to fight against this disappointing situation.
Several non-invasive methods, based on serum and imaging biomarkers, have aimed to identify at-risk patients for NAFLD-related fibrosis, but inconclusive results and many phenotypes that are present or not in patients (diabetes mellitus, obesity and age) reduce their diagnostic accuracy. Current strategies to monitor fibrosis are, therefore, inefficient and often fail to easily distinguish patients with mild disease that can be monitored at primary care from those at risk of advanced fibrosis or cirrhosis that need to receive specialised care and that could benefit from therapeutic interventions, such as participation in clinical trials and liver cancer surveillance programs.
The majority of patients with NAFLD are followed up in the community by general practitioners without definite diagnosis, representing a challenge to identify patients at risk of significant fibrosis who might benefit from an early specific intervention. Accurate fibrosis assessment by primary care or non-hepatologists physicians is limited by a reliance on liver function tests, which correlate poorly with fibrosis, and limited access to discriminatory fibrosis tests. Thus, current management strategies are inefficient in identifying subjects for specialist referral. Patients with mild disease are often referred for NAFLD specialist review when instead the appropriate preventative interventions of lifestyle changes can be delivered effectively in primary care. Conversely, patients with advanced fibrosis or cirrhosis who will benefit from NAFLD specific interventions, including clinical trials and cirrhosis surveillance, often remain undetected until they present with complications of cirrhosis, including hepatocellular carcinoma. This ineffective management contributes to the poor outcomes associated with liver disease and the increasing trends in NAFLD- related morbidity and mortality.
NASH-PI aims to improve the management of NAFLD patients by non-hepatologist physicians through the development of a new specific stepwise NAFLD algorithm following an ETC (Education, tools and communication) process that will be based on:
- The development of new care pathways based on different combinations of non-invasive tests that facilitate the derivation of diabetic patients from endocrine and primary care units to specialised liver disease units.
- Peer-to-peer sessions with primary care physicians and diabetologists to discuss the techniques and methods available to screen and detect diabetic patients at risk of developing NAFLD-related significant fibrosis.
- The implementation of easy and ready to use tools, like an automatic calculation of fNITs in central labs, to allow non-hepatologist physicians detect more efficiently diabetic patients at risk of significant fibrosis.
This proposal will focus on diabetic patients to test the feasibility and accuracy of these diagnostic strategies in a close circuit from primary care and diabetic clinics to NAFLD specialized Units (NSU). Our main goal is to create a NAFLD continuum of care that improves the selection of patients with fibrosis and cirrhosis for referral to secondary care, reducing unnecessary referrals, enhancing the use of healthcare resources with immediate cost-savings, and improving patient experiences by avoiding unnecessary clinic appointments and tests. NASH-PI will improve the identification of NAFLD in diabetic patients to allow for management according to current standard of care and impact on the disease course, helping to reduce NAFLD-related morbidity and mortality and delivering more efficient patient-centered care.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Current management of NAFLD patients in daily clinical practice | Experimental | Diagnostic Test: Derivation algorithmsIt will be taken as a reference for comparisons and will include the diagnosis and referral criteria that have been used the two previous years. CONSTANTS, a study included in the EPOS European Project has already allowed us to approach the burden of this entity in clinical practice in two sites of this consortium (Mainz and Sevilla). An overall analysis will be conducted to harmonize current standard of care (Arm A) in our centres. The case records of all patients referred with a diagnosis of NAFLD will be reviewed and evaluated for evidence of advanced fibrosis/cirrhosis based on a composite of history, physical examination, imaging, transient elastography, and liver histology when available. HFS, NFS, and FIB-4 scores will be calculated, and patients with a priori low-risk of advanced fibrosis will be deemed to have no evidence of liver fibrosis and thus referred inappropriately. |
| Arm B: Combination of blood-based non-invasive tests (HFS, NFS, and FIB-4) | Experimental | Diagnostic Test: Derivation algorithmsPatients will be assigned with the following scores: 1. 0 points if the value is under the lower cut-off (HFS <0.12; NFS<-1.455; FIB-4 <1.30); 2. 1 point if the value is allocated in the grey zone (HFS 0.12-0.47; NFS -1.455-0.676; FIB-4 1.30-2.67); 3. 2 points if the value is above the higher cut-off (HFS >0.47; NFS >0.676; FIB-4 >2.67). We will determine the optimal cut-offs (between 0 and 6 points) for keeping patients in non-specialized units or referring them to NSUs. * Age corrected threshold should be implemented in patients older than 65 years in NFS (from -1.455 to 0.12) and FIB-4 (from 1.30 to 2.00). |
| Arm C: Combination of HFS and TE | Experimental | Diagnostic Test: Derivation algorithmsPatients will be classified using the blood-based non-invasive tests to determine the HFS and a transient Elastography (TE). Patients with a HFS score of > 0.12 or TE >8 kPa for both M and XL probe should be classified as patients with an intermediate-to-high risk of advanced fibrosis and will be referred to a specialist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 75.
- Type 2 Diabetes Mellitus. Patients will be considered as diabetic when: A1C ≥6.5% OR FPG ≥126 mg/dL OR 2-h PG ≥200 mg/dl during the OGTT OR anti-diabetic drug users.
Key exclusion criteria (2 listed)
- Significant alcohol intake (>30 g daily for men and >20g daily for women).
- Evidence of concomitant liver disease (i.e., viral or autoimmune hepatitis, HIV, drug-induced fatty liver, hemochromatosis, or Wilson's disease).
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 |
|---|---|---|
| Derivation algorithmsDerivation algorithm based on non-invasive methods, to standardise the continuum of care for diabetic patients with NAFLD from primary care and endocrinology settings to NAFLD specialised units (NSU) | Diagnostic test | Arm A: Current management of NAFLD patients in daily clinical practice, Arm B: Combination of blood-based non-invasive tests (HFS, NFS, and FIB-4), Arm C: Combination of HFS and TE |
Primary outcome
Accuracy on referral rate
Time frame: Up to 6 months
To determine the accuracy on referral rate for diabetic patients at risk of advanced fibrosis using each of the strategies under study, and determine the sensitivity, specificity, PPV, NPV, likelihood ratios and overall accuracy of each of them.
7 secondary outcomes
Cut-off scores for fibrosis non-invasive tests (fNITs)
Time frame: 3 months
Cut-off score for Hepamet Fibrosis Score (HFS) + Transient Elastography (TE)
Time frame: 3 months
Evaluation of quality-adjusted life years (QALYs)
Time frame: 9 months
Evaluation of Incremental Cost-Effectiveness Ratios (ICERs)
Time frame: 9 months
Patient reported diet habits
Time frame: 6 months
Patient reported physical activity
Time frame: 6 months
Patient reported individual functioning
Time frame: 6 months
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 14 Nov 2024.
- 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.
Manuel Romero-Gómez principal investigator
Hospital Universitario Virgen del Rocío de Sevilla
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Derivation algorithms in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 4 sites in 3 countries.
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 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: finished, as of the sponsor's last update on 14 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 4 sites in Germany, Greece, 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?
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?
Accuracy on referral rate (time frame: Up to 6 months). 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 14 Nov 2024.