Serial Transient Elastography Examinations to Monitor Patients With Type 2 Diabetes: A Prospective Cohort Study

Abstract

BaCKgRoUND aND aIMS: Type 2 diabetes is an important risk factor for nonalcoholic fatty liver disease (NAFLD) and advanced fibrosis. Current international guidelines recommend the use of noninvasive tests as initial assessments for NAFLD, but the role of noninvasive tests as monitoring tools has not been established. We aimed to study the role of transient elastography as a monitoring tool in patients with type 2 diabetes. appRoaCH aND ReSUltS: We recruited patients with type 2 diabetes without viral hepatitis or excessive alcohol intake from a complication screening facility in Hong Kong in 2013-2014 and repeated the assessments in 2016-2018. The primary endpoint was an increase of liver stiffness measurement (LSM) to ≥10 kPa. The secondary endpoint was the change in the controlled attenuation parameter (CAP). A total of 611 patients with type 2 diabetes and a valid LSM (mean age, 57.7 ± 10.9 years; 342 men [56.0%]) were included in this study (568 also had a valid CAP). Overall, there was moderate correlation between the baseline and followup LSM (r = 0.689, P < 0.001). Among 487 patients with a baseline LSM <10 kPa, 21 (4.3%) had a follow-up LSM ≥10 kPa. Baseline body mass index, alanine aminotransferase (ALT), and ∆ALT were independent factors associated with LSM increase. Among 124 patients with a baseline LSM ≥10 kPa, 70 (56.5%) had a follow-up LSM <10 kPa. Among 198 patients with a CAP <248 dB/m at baseline, 103 (52.0%) had a CAP increased to ≥248 dB/m. CoNClUSIoNS: The prevalence and incidence of NAFLD in patients with type 2 diabetes are high. Although advanced fibrosis is common in this population, few patients progress to advanced fibrosis in 3 years. Future studies should define the optimal surveillance interval in patients with diabetes.

Clinical spectrum of non-alcoholic fatty liver disease in patients with diabetes mellitus

“…Admittedly, a single TE result in our cross-sectional study may not be a true reflection of patient’s fibrosis status as it can be confounded by several factors such as obesity, alcohol/food consumption, or operator-dependence. Indeed, a prospective study by Lee et al investigating serial TE examinations in T2DM patients demonstrated that more than half of the patients had LSM reduction in 3 years [ 31 ]. Nevertheless, TE has been endorsed as an alternative to liver biopsy by international guidelines in guiding clinical management of chronic liver disease, including NAFLD [ 11 , 32 ].…”

A prospective 5-year study on the use of transient elastography to monitor the improvement of non-alcoholic fatty liver disease following bariatric surgery

“…In 14 out of 34 patients, paired liver biopsies were available and the changes in LSM were shown to have correlation with the change in histological fibrosis stage. In a large scale study of 611 diabetic patients conducted by Lee et al, monitoring by TE could identify fibrosis progression (from LSM < 10 kPa to LSM ≥ 10 kPa) and steatosis progression (from CAP < 248 dB/m to CAP ≥ 248 dB/m) in 4.3% and 52.0% of patients, respectively, over 3 years 23 . As for the longitudinal monitoring of response to treatment for NAFLD, TE had been adopted as a monitoring tool in a few prospective studies 24 , 25 .…”

“…To the best of our knowledge, our study was the first study to evaluate the long-term treatment responses of NAFLD to bariatric surgery using TE as a monitoring tool. In the literature, TE had been tested on the roles of monitoring disease progression and response to treatment of NAFLD [21][22][23][24][25] . Suzuki et al reported the changes of LSM over 4 years in 36 patients without paired liver biopsies for monitoring disease progression of NAFLD 21 .…”

Clinical assessment and management of liver fibrosis in non-alcoholic fatty liver disease

“…The limitation is that occasionally measurements cannot be obtained in obese patients[ 49 , 77 ], reliable LSM measurements are obtained in about 80% to 90% of NASH/NAFLD patients[ 78 , 79 ]. It is noteworthy that at least three hours of fasting are necessary before evaluation with TE since a significant increase in LSM has been observed in patients with less than two hours of fasting[ 80 ]. In addition to this, there are quality standards that should be met to consider the result as adequate: At least 10 valid measurements (60% of success) and an IQR < 30%[ 81 ].…”

“…Around 20% had advanced liver fibrosis at baseline, but only 4% developed advanced fibrosis in 3 years. Baseline BMI, ALT, and ∆ALT independently predicted LSM increase[ 80 ]. Based on this data, we could advise performing TE every three years only in patients with risk factors such as T2DM, elevated BMI, and ALT above the UNL, otherwise, TE could be performed every 5 years.…”