NAFLD in Diabetes Type 2 in Primary Care

Linkoeping University317 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

317

Conditions

NAFLD

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (2)

Ekholmen primary health care centre

Linköping, Swedish, Sweden

Åby primary health care centre

Norrköping, Sweden

Outcomes

Primary Outcomes

Prevalence of fatty liver

Number of patients with fatty liver measured with MR-PDFF

Time frame: 2020

Prevalence of advanced liver disease

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

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 2020

Secondary Outcomes

Health economic model for disease management

Markow model

Time frame: 2025

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

Data from ClinicalTrials.gov

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