Nasr Patrik, Iredahl Fredrik, Dahlström Nils, Rådholm Karin, Henriksson Pontus, Cedersund Gunnar, Dahlqvist Leinhard Olof, Ebbers Tino, Alfredsson Joakim, Carlhäll Carl-Johan, Lundberg Peter, Kechagias Stergios, Ekstedt Mattias
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Center for Medical Image Science and Visualization (CMIV), Linköping University, Linköping, Sweden.
BMC Gastroenterol. 2021 Apr 20;21(1):180. doi: 10.1186/s12876-021-01763-z.
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.
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.
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.
Clinicaltrials.gov, identifier NCT03864510. Registered 6 March 2019, https://clinicaltrials.gov/ct2/show/NCT03864510 .
非酒精性脂肪性肝病（NAFLD）影响20% - 30%的成年普通人群。患有2型糖尿病（T2DM）的NAFLD患者发生晚期肝纤维化的风险增加，这使他们面临心血管并发症、肝细胞癌或肝衰竭的风险。肝活检是评估肝纤维化的金标准。然而，其应用存在固有局限性。因此，患有晚期肝纤维化的T2DM患者的患病率和特征尚不清楚。所以，本研究的目的是通过从初级保健机构招募参与者，使用最新的成像方式，收集一组表型良好的患者，来评估T2DM患者中NAFLD的患病率和严重程度。
我们将前瞻性招募400例T2DM患者，使用生物标志物评估他们的状况。具体而言，我们将使用磁共振成像（MRI）评估肝脏脂肪含量；使用磁共振弹性成像和振动控制瞬时弹性成像评估肝纤维化；使用水脂分离全身MRI评估肌肉组成和体脂分布；使用心血管MRI评估心脏功能、结构和组织特征。
我们预计该研究将揭示NAFLD和T2DM中晚期肝纤维化的潜在机制，并为临床医生提供更好的诊断工具，用于治疗患有NAFLD的T2DM患者。
Clinicaltrials.gov，标识符NCT03864510。于2019年3月6日注册，https://clinicaltrials.gov/ct2/show/NCT03864510 。
