NAFLDEPSONIPNCT03864510
NAFLD in Diabetes Type 2 in Primary Care
An observational study of NAFLD, run by Linkoeping University at 2 sites in Sweden.
Trial summary
The EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- NAFLD
- How many people
- 317 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Apr 2019to 1 Dec 2023
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutively enrolled patients with diabetes type 2 in primary care.
Who may be able to join
- Diabetes type 2
- Age 35-75 year
Who cannot join
- Contraindication to MR
- Alcohol dependance
- Previously diagnosed liver cirrhosis
- Previously known liver disease (other than fatty liver)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Ekholmen primary health care centre
Linköping, Swedish, 58185
Åby primary health care centre
Norrköping
About this study
Official title: Evaluating Prevalence and Severity of NAFLD In Primary Care
The EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. The latest MRI techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. Each patient will be investigated twice with three years apart to determine patients with progressive disease.
- Conditions
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of fatty liver
Number of patients with fatty liver measured with MR-PDFF
Measured: 2020
Prevalence of advanced liver disease
Number of patients with advanced liver disease (fibrosis stage > 2)
Measured: 2020
The association between physical activity and advanced liver disease (fibrosis >2)
Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with the international fitness scale (IFIS)
Measured: 2020
The association between physical activity and advanced liver disease (fibrosis >2)
Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with Actigraph GT3X (accelerometer)
Measured: 2020
The association between fitness and advanced liver disease (fibrosis >2)
Liver fibrosis measured with MRE and liver biopsy. Fitness measured with the six minute walk test.
Measured: 2020
Genetic factors associated with advanced liver disease (fibrosis >2)
Liver fibrosis measured with MRE and liver biopsy. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT
Measured: 2020
Secondary outcomes (2)
Health economic model for disease management
Markow model
Measured: 2025
Number of patients that develop symptoms of end-stage liver disease
Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review
Measured: 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mattias Ekstedt, Linkoeping University
- Investigators
- Mattias Ekstedt, MD, PhD, Principal investigator, LiU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864510
- Sponsor's protocol ID
- 2018:176-31
- Acronym
- EPSONIP
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2019
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bergram M, Kechagias S, Iredahl F, Balkhed W, Holmberg M, Dahlstrom N, Lundberg P, Nasr P, Ekstedt M, Radholm K. Microvascular complications of type 2 diabetes with or without MASLD: the EPSOMIP study, a primary care cohort study. BMC Prim Care. 2025 Nov 11;26(1):354. doi: 10.1186/s12875-025-03096-2.
PubMed 41219835Nasr P, Iredahl F, Dahlstrom N, Radholm K, Henriksson P, Cedersund G, Dahlqvist Leinhard O, Ebbers T, Alfredsson J, Carlhall CJ, Lundberg P, Kechagias S, Ekstedt M. Evaluating the prevalence and severity of NAFLD in primary care: the EPSONIP study protocol. BMC Gastroenterol. 2021 Apr 20;21(1):180. doi: 10.1186/s12876-021-01763-z.
PubMed 33879084
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Prevalence and Severity of NAFLD In Primary Care
- ClinicalTrials.gov ID
- NCT03864510
- Acronym / sponsor ID
- EPSONIP / 2018:176-31
- Conditions
- NAFLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 Mar 2019 (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 EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. The latest MRI techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. Each patient will be investigated twice with three years apart to determine patients with progressive disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutively enrolled patients with diabetes type 2 in primary care.
Key inclusion criteria (2 listed)
- Diabetes type 2
- Age 35-75 year
Key exclusion criteria (4 listed)
- Contraindication to MR
- Alcohol dependance
- Previously diagnosed liver cirrhosis
- Previously known liver disease (other than fatty liver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of fatty liver
Time frame: 2020
Number of patients with fatty liver measured with MR-PDFF
Prevalence of advanced liver disease
Time frame: 2020
Number of patients with advanced liver disease (fibrosis stage > 2)
The association between physical activity and advanced liver disease (fibrosis >2)
Time frame: 2020
Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with the international fitness scale (IFIS)
The association between physical activity and advanced liver disease (fibrosis >2)
Time frame: 2020
Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with Actigraph GT3X (accelerometer)
The association between fitness and advanced liver disease (fibrosis >2)
Time frame: 2020
Liver fibrosis measured with MRE and liver biopsy. Fitness measured with the six minute walk test.
Genetic factors associated with advanced liver disease (fibrosis >2)
Time frame: 2020
Liver fibrosis measured with MRE and liver biopsy. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT
2 secondary outcomes
Health economic model for disease management
Time frame: 2025
Number of patients that develop symptoms of end-stage liver disease
Time frame: 2030
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 Dec 2025.
- Derived from this study: PubMed 41219835Bergram M, Kechagias S, Iredahl F, Balkhed W, Holmberg M, Dahlstrom N, Lundberg P, Nasr P, Ekstedt M, Radholm K. Microvascular complications of type 2 diabetes with or without MASLD: the EPSOMIP study, a primary care cohort study. BMC Prim Care. 2025 Nov 11;26(1):354. doi: 10.1186/s12875-025-03096-2.
- Derived from this study: PubMed 33879084Nasr P, Iredahl F, Dahlstrom N, Radholm K, Henriksson P, Cedersund G, Dahlqvist Leinhard O, Ebbers T, Alfredsson J, Carlhall CJ, Lundberg P, Kechagias S, Ekstedt M. Evaluating the prevalence and severity of NAFLD in primary care: the EPSONIP study protocol. BMC Gastroenterol. 2021 Apr 20;21(1):180. doi: 10.1186/s12876-021-01763-z.
- Individual participant dataSharing planned: Undecided
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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.
Mattias Ekstedt, MD, PhD principal investigator
LiU
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 NAFLD, run by Linkoeping University at 2 sites in Sweden.
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 4 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 Dec 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 Sweden. 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?
Prevalence of fatty liver (time frame: 2020). The study lists 6 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 NCT03864510, which also lists 2 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 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.