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NAFLD in Diabetes Type 2 in Primary Care

Evaluating Prevalence and Severity of NAFLD In Primary Care

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03864510
Acronym
EPSONIP
Enrollment
317
Registered
2019-03-06
Start date
2019-04-01
Completion date
2023-12-01
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD

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.

Interventions

None listed

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of advanced liver disease2020Number of patients with advanced liver disease (fibrosis stage \> 2)
The association between fitness and advanced liver disease (fibrosis >2)2020Liver fibrosis measured with MRE and liver biopsy. Fitness measured with the six minute walk test.
Genetic factors associated with advanced liver disease (fibrosis >2)2020Liver fibrosis measured with MRE and liver biopsy. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT
Prevalence of fatty liver2020Number of patients with fatty liver measured with MR-PDFF
The association between physical activity and advanced liver disease (fibrosis >2)2020Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with the international fitness scale (IFIS)

Secondary

MeasureTime frameDescription
Number of patients that develop symptoms of end-stage liver disease2030Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review
Health economic model for disease management2025Markow model

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026