PMID- 33879084 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20231111 IS - 1471-230X (Electronic) IS - 1471-230X (Linking) VI - 21 IP - 1 DP - 2021 Apr 20 TI - Evaluating the prevalence and severity of NAFLD in primary care: the EPSONIP study protocol. PG - 180 LID - 10.1186/s12876-021-01763-z [doi] LID - 180 AB - BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) affects 20-30% of the general adult population. NAFLD patients with type 2 diabetes mellitus (T2DM) are at an increased risk of advanced fibrosis, which puts them at risk of cardiovascular complications, hepatocellular carcinoma, or liver failure. Liver biopsy is the gold standard for assessing hepatic fibrosis. However, its utility is inherently limited. Consequently, the prevalence and characteristics of T2DM patients with advanced fibrosis are unknown. Therefore, the purpose of the current study is to evaluate the prevalence and severity of NAFLD in patients with T2DM by recruiting participants from primary care, using the latest imaging modalities, to collect a cohort of well phenotyped patients. METHODS: We will prospectively recruit 400 patients with T2DM using biomarkers to assess their status. Specifically, we will evaluate liver fat content using magnetic resonance imaging (MRI); hepatic fibrosis using MR elastography and vibration-controlled transient elastography; muscle composition and body fat distribution using water-fat separated whole body MRI; and cardiac function, structure, and tissue characteristics, using cardiovascular MRI. DISCUSSION: We expect that the study will uncover potential mechanisms of advanced hepatic fibrosis in NAFLD and T2DM and equip the clinician with better diagnostic tools for the care of T2DM patients with NAFLD. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT03864510. Registered 6 March 2019, https://clinicaltrials.gov/ct2/show/NCT03864510 . FAU - Nasr, Patrik AU - Nasr P AUID- ORCID: 0000-0002-2928-4188 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Iredahl, Fredrik AU - Iredahl F AUID- ORCID: 0000-0002-4245-7565 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Dahlstrom, Nils AU - Dahlstrom N AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. AD - Center for Medical Image Science and Visualization (CMIV), Linkoping University, Linkoping, Sweden. FAU - Radholm, Karin AU - Radholm K AUID- ORCID: 0000-0003-3120-0913 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Henriksson, Pontus AU - Henriksson P AUID- ORCID: 0000-0003-2482-7048 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Cedersund, Gunnar AU - Cedersund G AD - Center for Medical Image Science and Visualization (CMIV), Linkoping University, Linkoping, Sweden. AD - Department of Biomedical Engineering, Linkoping University, Linkoping, Sweden. FAU - Dahlqvist Leinhard, Olof AU - Dahlqvist Leinhard O AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. AD - Center for Medical Image Science and Visualization (CMIV), Linkoping University, Linkoping, Sweden. AD - AMRA Medical AB, Linkoping, Sweden. FAU - Ebbers, Tino AU - Ebbers T AUID- ORCID: 0000-0003-1395-8296 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Alfredsson, Joakim AU - Alfredsson J AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Carlhall, Carl-Johan AU - Carlhall CJ AUID- ORCID: 0000-0003-2198-9690 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. AD - Department of Clinical Physiology in Linkoping, Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Lundberg, Peter AU - Lundberg P AUID- ORCID: 0000-0001-8661-2232 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. AD - Center for Medical Image Science and Visualization (CMIV), Linkoping University, Linkoping, Sweden. FAU - Kechagias, Stergios AU - Kechagias S AUID- ORCID: 0000-0001-7614-739X AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. FAU - Ekstedt, Mattias AU - Ekstedt M AUID- ORCID: 0000-0002-5590-8601 AD - Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden. mattias.ekstedt@liu.se. AD - Center for Medical Image Science and Visualization (CMIV), Linkoping University, Linkoping, Sweden. mattias.ekstedt@liu.se. LA - eng SI - ClinicalTrials.gov/NCT03864510 GR - ALF Grants/Region Ostergotland/ GR - Non-restricted Grant/Gilead Foundation/ GR - Non-restricted Grant/Diapharma/ GR - Lion Research Grant/Faculty of Medicine, Linkoping University/ GR - VR 2020-04826/Vetenskapsradet/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20210420 PL - England TA - BMC Gastroenterol JT - BMC gastroenterology JID - 100968547 SB - IM MH - Adult MH - *Diabetes Mellitus, Type 2/complications/epidemiology MH - Humans MH - Liver Cirrhosis MH - *Non-alcoholic Fatty Liver Disease/complications/diagnostic imaging/epidemiology MH - Prevalence MH - Primary Health Care MH - Risk Factors PMC - PMC8056630 OTO - NOTNLM OT - Biomarkers OT - Cirrhosis OT - Non-alcoholic fatty liver disease OT - T2DM OT - Type 2 diabetes mellitus COIS- The authors declare that they have no competing interests. EDAT- 2021/04/22 06:00 MHDA- 2021/05/15 06:00 PMCR- 2021/04/20 CRDT- 2021/04/21 05:38 PHST- 2021/02/19 00:00 [received] PHST- 2021/04/12 00:00 [accepted] PHST- 2021/04/21 05:38 [entrez] PHST- 2021/04/22 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2021/04/20 00:00 [pmc-release] AID - 10.1186/s12876-021-01763-z [pii] AID - 1763 [pii] AID - 10.1186/s12876-021-01763-z [doi] PST - epublish SO - BMC Gastroenterol. 2021 Apr 20;21(1):180. doi: 10.1186/s12876-021-01763-z.