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

NCT07312136 | Enrolling By Invitation DMC

• 1 other identifier: 2024-05471-01
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

MASLD; Fibroscan; PDFF; MRE; Obesity

Outcome Measures

Primary Outcomes (10)

• Prevalence of MASLD

  Number of patients with MASLD measured with MRI-PDFF or CAP

  2031

• Progression/regression of MASLD

  Number of patients who progress/regress to/from MASLD between two timepoints as measured with MRI-PDFF or CAP

  2031

• Predictors of MASLD progression/regression

  Liver fat measured with MRI-PDFF. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.

  2031

• Prevalence of advanced fibrosis

  Number of patients with advanced liver disease as defined by VCTE or MRE (or clinically, i.e., signos of cirrohsis or hepatic decompensation)

  2031

• Progression/regression of advanced fibrosis

  Progression/regression to/from advanced liver disease as measured with VCTE or MRE between two timepoints

  2031

• Predictors of fibrosis progression/regression

  Liver fibrosis measured with MRE or VCTE. Predicitive variables collected through clinical evaluation, blood tests, physical activitiy evaluation, OSAS evaluation, hypertension measurements among others.

  2031

• The association between physical activity and prevalent advanced fibrosis

  Liver fibrosis measured with VCTE or MRE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).

  2031

• The association between physical activity and risk of progressing to advanced fibrosis

  Liver fibrosis measured with MRE or VCTE. Physical activity measured with the international fitness scale (IFIS) and/or Actigraph GT3X (accelerometer).

  2031

• Genetic factors associated with advanced fibrosis or MASLD progression/regression

  Liver fibrosis measured with MRE and VCTE. Liver fat measured with MRI-PDFF and CAP. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT among others.

  2031

• Association between body composition and MASLD and/or liver fibrosis and progression/regression thereof

  Liver fat measured with MRI-PDFF or CAP. Liver fibrosis measured with MRE or VCTE. Body composition measured with AMRA Medical AB's MAsS Scan.

  2031

Secondary Outcomes (4)

• The association of hypertension and MASLD (with or withour signs of advanced fibrosis)

  2031

• The association between OSAS and MASLD (with or withour advanced fibrosis)

  2031

• Health economic model for disease management

  2034

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

  2035

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who where previously included, and fulfilled participation, in the EPSONIP trial (NCT03864510) between 2019 and 2023 are re-invited to fulfill the same evaluation with additional tests.

You may qualify if:

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

You may not qualify if:

• Contraindication to magnetic resonance
• Liver transplantation

Sponsors & Collaborators

• Linkoeping University: lead
• University Hospital, Linkoeping: collaborator
• Amra Medical AB: collaborator

Study Sites (1)

Department of Gastroenterology and Hepatology, Linköping University Hospital

Linköping, Östergötland County, 58185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA, RNA, urine

MeSH Terms

Conditions

Fibrosis; Sarcopenia; Obesity; Overweight; Diabetes Mellitus, Type 2; Hypertension; Sleep Apnea, Obstructive; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Insulin Resistance; Hyperinsulinism

Study Officials

• Patrik Nasr, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj Associate Professor, Docent, Specialist doctor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2034
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

SE (1)