Background

International guidelines suggest screening for advanced fibrosis due to metabolic dysfunction-associated steatotic liver disease in people with type 2 diabetes, but how to implement these guidelines in clinical care remains unclear. We hypothesise that examination with VCTE could be implemented simultaneously with retina scanning with a high acceptance rate in people with type 2 diabetes.

Methods

In this cross-sectional study, we offered VCTE to people with type 2 diabetes referred to routine retina scanning in a large retina scanning facility in Stockholm, Sweden. We excluded people with type 1 diabetes, currently pregnant, with known liver disease, reporting high alcohol consumption, who did not speak Swedish, or younger than 18 years. Between Nov 6, 2020, and June 20, 2023, we conducted surveys with included participants and collected data from medical records on diabetes retinopathy, sex, and VCTE measurements. Increased liver stiffness was defined as at least 8·0 kPa, and possible advanced fibrosis as more than 12·0 kPa. Presence of metabolic dysfunction-associated steatotic liver disease was defined as a controlled attenuation parameter (CAP) value of 280 dB/m or higher. Participants with a liver stiffness measurement of at least 8·0 kPa or those with unreliable measurements were subsequently referred for a secondary evaluation at a liver specialist, including a follow-up liver stiffness measurement with VCTE. The primary outcome was the proportion of eligible people approached for screening who accepted. Secondary outcomes were the prevalence of elevated liver stiffness (≥8·0 kPa or >12·0 kPa), presence of metabolic dysfunction-associated steatotic liver disease, and the proportion of elevated liver stiffness readings at the first VCTE examination that were not elevated in the secondary evaluation with a liver specialist. Secondary outcomes were assessed in all participants who accepted screening, except false positives, which were assessed only in participants who had a second examination.

Findings

1301 participants were eligible to undergo assessment with VCTE, which was accepted by 1005 (77·2%). 973 (96·8%) participants had complete measurements, of whom 504 (51·8%) had CAP values of 280 dB/m or higher, indicating metabolic dysfunction-associated steatotic liver disease. Of 977 participants with reliable liver stiffness measurements, 154 (15·8%) had values of at least 8·0 kPa, suggestive of liver fibrosis, and 49 (5·0%) had values higher than 12·0 kPa, indicating possible advanced fibrosis. However, upon reassessment with a second VCTE after referral, 56 (45·2%) of 124 individuals had values less than 8·0 kPa. 74 (7·4%) of 1005 participants had a final liver stiffness of at least 8·0 kPa; 29 (2·9%) had values greater than 12·0 kPa.

Interpretation

Simultaneous examination with VCTE alongside retina scanning had a high acceptance rate among people with type 2 diabetes and could be a strategy for case-finding of people with fibrosis due to metabolic dysfunction-associated steatotic liver disease. However, a high proportion of participants in our study with elevated liver stiffness measurement at the screening visit did not have an elevated liver stiffness measurement at secondary evaluation, suggesting false-positive findings were common.

Funding

Gilead Sciences, Pfizer, Region Stockholm, Åke Wiberg Foundation, and Bengt Ihre Foundation.

中文翻译：

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在 2 型糖尿病患者中筛查代谢功能障碍相关脂肪性肝病引起的晚期肝纤维化和视网膜扫描：一项横断面研究

 背景

国际指南建议对 2 型糖尿病患者进行代谢功能障碍相关脂肪性肝病引起的晚期纤维化筛查，但如何在临床护理中实施这些指南仍不清楚。我们假设 VCTE 检查可以与视网膜扫描同时进行，在 2 型糖尿病患者中的接受率很高。

 方法

在这项横断面研究中，我们为 2 型糖尿病患者提供了 VCTE，该患者在瑞典斯德哥尔摩的大型视网膜扫描设施中进行了常规视网膜扫描。我们排除了 1 型糖尿病患者、目前怀孕、已知患有肝病、报告饮酒量高、不会说瑞典语或年龄小于 18 岁的人。在 2020 年 11 月 6 日至 2023 年 6 月 20 日期间，我们对纳入的参与者进行了调查，并从糖尿病视网膜病变、性别和 VCTE 测量的医疗记录中收集了数据。肝脏硬度增加定义为至少 8·0 kPa，可能的晚期纤维化定义为超过 12·0 kPa。存在代谢功能障碍相关的脂肪性肝病定义为受控衰减参数 （CAP） 值为 280 dB/m 或更高。肝脏硬度测量值至少为 8·0 kPa 或测量值不可靠的参与者随后被转介到肝脏专家处进行二次评估，包括使用 VCTE 进行后续肝脏硬度测量。主要结局是接受筛查的合格人群的比例。次要结局是肝脏硬度升高的患病率 （≥8·0 kPa 或 >12·0 kPa），存在代谢功能障碍相关的脂肪性肝病，以及第一次 VCTE 检查时肝脏硬度读数升高的比例，在肝脏专家的二次评估中未升高。在所有接受筛查的参与者中评估了次要结局，但假阳性除外，假阳性仅在进行第二次检查的参与者中进行评估。

 发现

1301 名参与者有资格接受 VCTE 评估，1005 名 （77·2%） 接受了评估。973 名 （96·8%） 参与者进行了完整的测量，其中 504 名 （51·8%） 的 CAP 值为 280 dB/m 或更高，表明代谢功能障碍相关的脂肪性肝病。在 977 名肝脏硬度测量可靠的参与者中，154 名 （15·8%） 的值至少为 8·0 kPa，提示肝纤维化，49 名 （5·0%） 的值高于 12·0 kPa，表明可能存在晚期纤维化。然而，在转诊后使用第二次 VCTE 重新评估时，124 个个体中有 56 个 （45·2%） 的值小于 8·0 kPa。1005 名参与者中有 74 名 （7·4%） 的最终肝脏硬度至少为 8·0 kPa;29 例 （2·9%） 的值大于 12·0 kPa。

 解释

VCTE 与视网膜扫描同时检查在 2 型糖尿病患者中具有很高的接受率，并且可能成为代谢功能障碍相关脂肪性肝病引起的纤维化患者的病例发现策略。然而，在我们的研究中，很大一部分参与者在筛选访视时肝脏硬度测量值升高，但在二次评估时肝脏硬度测量值没有升高，这表明假阳性结果很常见。

 资金

吉利德科学公司、辉瑞公司、斯德哥尔摩地区公司、Åke Wiberg 基金会和 Bengt Ihre 基金会。