Skip to main content
OpenTrials
Completed

NCT Number: NCT03864510

NAFLD in Diabetes Type 2 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ekholmen primary health care centre, Linköping, Swedish, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes type 2
  • Age 35-75 year

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Prevalence of fatty liver

    Time frame: 2020

    Number of patients with fatty liver measured with MR-PDFF

  2. Prevalence of advanced liver disease

    Time frame: 2020

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

  3. 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)

  4. 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)

  5. 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.

  6. 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

Secondary outcomes

  1. Health economic model for disease management

    Time frame: 2025

    Markow model

  2. Number of patients that develop symptoms of end-stage liver disease

    Time frame: 2030

    Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Evaluating Prevalence and Severity of NAFLD In Primary Care

Acronym: EPSONIP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2019
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.