MASLD in Type 2 Diabetes in Primary Care - a Follow-up Study

NCT ID: NCT07312136

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-16

Study Completion Date

2034-12-31

Brief Summary

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The EPSOMIP2 (Evaluating the Prevalence and Severity Of MASLD In Primary care - a Follow-up Study) trial is a longitudinal cohort study of patients with type 2 diabetes recruited from primary health care centers in Östergötland, Sweden. Between 2019-2023, 317 patients were included and underwent rigorous clinical evaluation, vibration controlled transient elastography, biobanking of bloodsamples, and the latest magnetic resonance techniques to liver and body composition. All patients alive will be re-invited to undergo the same evaluation and additional tests.

Detailed Description

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Conditions

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MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Cirrhosis Advanced Fibrosis Sarcopenia Obesity & Overweight Type 2 Diabetes Hypertension OSAS (Obstructive Sleep Apneas Syndrome) Metabolic Syndrome

Keywords

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MASLD Fibroscan PDFF MRE Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Previously included and fulfilled evaluation in EPSONIP trial (NCT03864510)
* Age \>/= 18 years
* Informed consent

Exclusion Criteria

* Contraindication to magnetic resonance
* Other primary liver disease than MASLD diagnosed after inclusion EPSONIP trial (NCT03864510)
* Liver transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Amra Medical AB

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Patrik Nasr

Adj Associate Professor, Docent, Specialist doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrik Nasr, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Health, Medicine and Caring Sciences, Linköping University, and Department of Gastroenterology and Hepatology, Linköping University Hospital, Linköping, Sweden

Locations

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Department of Gastroenterology and Hepatology, Linköping University Hospital

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2024-05471-01

Identifier Type: -

Identifier Source: org_study_id