NAFLD in Diabetes Type 2 in Primary Care

NAFLD Clinical Trial

— EPSONIP  

Official title:

Evaluating Prevalence and Severity of NAFLD In Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864510
• Other study ID #: 2018:176-31
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Sweden	Ekholmen primary health care centre	Linköping	Swedish
Sweden	Åby primary health care centre	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of fatty liver	Number of patients with fatty liver measured with MR-PDFF	2020
Primary	Prevalence of advanced liver disease	Number of patients with advanced liver disease (fibrosis stage > 2)	2020
Primary	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
Primary	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
Primary	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
Primary	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	Health economic model for disease management	Markow model	2025
Secondary	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	2030