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| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
| Amra Medical AB | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The association of hypertension and MASLD (with or withour signs of advanced fibrosis) | Liver fibrosis measured with MRE or VCTE. Hypertension measured with weekly blood pressure measurement and/or 24 hour blood pressure measurement. | 2031 |
| The association between OSAS and MASLD (with or withour advanced fibrosis) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology, Linköping University Hospital | Linköping | Östergötland County | 58185 | Sweden |
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Serum, Plasma, DNA, RNA, urine
| 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 |
Liver fat measured with MRI-PDFF or CAP. Liver fibrosis measured with VCTE or MRE. OSAS measured at university hospital sleep apnea. |
| 2031 |
| Health economic model for disease management | Markov modelling | 2034 |
| 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 | 2035 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D055948 | Sarcopenia |
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D020181 | Sleep Apnea, Obstructive |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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