NCT03864510

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 12, 2025

Status Verified

March 1, 2024

Enrollment Period

4.7 years

First QC Date

February 12, 2019

Last Update Submit

December 5, 2025

Conditions

NAFLD

Outcome Measures

Primary Outcomes (6)

  • Prevalence of fatty liver

    Number of patients with fatty liver measured with MR-PDFF

    2020

  • Prevalence of advanced liver disease

    Number of patients with advanced liver disease (fibrosis stage \> 2)

    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)

    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)

    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.

    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

    2020

Secondary Outcomes (2)

  • Health economic model for disease management

    2025

  • Number of patients that develop symptoms of end-stage liver disease

    2030

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutively enrolled patients with diabetes type 2 in primary care.

You may qualify if:

  • Diabetes type 2
  • Age 35-75 year

You may not qualify if:

  • Contraindication to MR
  • Alcohol dependance
  • Previously diagnosed liver cirrhosis
  • Previously known liver disease (other than fatty liver)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ekholmen primary health care centre

Linköping, Swedish, 58185, Sweden

Location

Åby primary health care centre

Norrköping, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 41219835DERIVED

  • Nasr 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.

    PMID: 33879084DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA, RNA, liver tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Mattias Ekstedt, MD, PhD

    LiU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer/Consultant

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 6, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 12, 2025

Record last verified: 2024-03

Locations

SE(2)