Clinical trial NCT06694974: Liver Fibrosis Assessment in Diabetic Patients
Official title: A Randomized Controlled Trial for Liver Fibrosis Assessment in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: Type 2 diabetes patients
metabolic dysfunction-associated steatotic liver disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 540
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).

Detailed description: Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in people with type 2 diabetes. Patients with prediabetes/type 2 diabetes or 2 or more metabolic risk factors are at higher risk for hepatic fibrosis. Type 2 diabetes increases the risk of cirrhosis, cirrhotic complications and liver-related mortality. According to the American Gastroenterology Association guideline, NAFLD screening should be considered for individuals older than 40 years with type 2 diabetes mellitus.

The American diabetes association now advises screening all adults with type 2 diabetes or prediabetes, particularly those with obesity or cardiometabolic risk factors or established cardiovascular disease for clinically significant liver fibrosis (defined as moderate fibrosis to cirrhosis) using a calculated fibrosis-4 index (FIB-4), even those with normal liver enzyme levels.4 People with type 1 diabetes who have obesity, hepatic steatosis, or elevated aminotransferases should also screen for NAFLD. The recommended screening tool is the fibrosis-4 index (FIB-4), a calculation that includes the patient's age, liver enzyme levels, and platelet counts. A score of 1.3 or higher is considered high risk for clinically significant fibrosis, and above 2.67 is very high-risk.

According to a recent study of 1918 patients who received screening Fibroscan, 72.8% had steatosis, and 17.1% had advanced fibrosis (Fibroscan \>= 9.6kpa). In another study in Malaysia, among 557 type 2 DM patients who received Fibroscan, 72.4% had NAFLD, and 21% had advanced fibrosis(Fibroscan \>= 9.6kpa). Another study screened 561 type 2 diabetes patients in the US, 70% had steatosis, and 9% had advanced fibrosis (Fibroscan \>= 9.7kpa). Overall, the prevalence of steatotic liver disease is 70%, and the percentage of advanced fibrosis (\>=F3) is 9-21%.

However, the screening of NAFLD in type 2 diabetes patients are underutilized. Because there is still a significant knowledge gap in the clinicians for the identification, diagnosis, and management of NAFLD. There is no country had a national or subnational strategy for NAFLD. Several clinical pathways to facilitate the evaluation of NAFLD in type 2 diabetes patients are developing now. Instead of relying on active assessment by clinicians, automated fibrosis score calculation using the FIB-4 index followed by reminder messages in the electronic clinical management system increased appropriate referral for hepatology assessment or further fibrosis tests in patients with increased fibrosis scores from 3.1% to 33.3%. However, there is still more than 2/3 of patients was not referred for further fibrosis evaluation.

The electronic notification system is not widely available for all clinics, while nearly every patient has the mobile phone. Applying the notification system through the smartphone APP is beneficial for the patients to participate actively for their personal health management and improving disease awareness.

The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes patients, regular follow-up in OPD every 3 months
2. Age 35-65 (Because FIB-4 is not accurate in people with age \<35 or \> 65)

Exclusion Criteria:

1. Patients are regularly follow the investigators at the liver clinic for liver disease
2. Active malignancy
3. Hematology disease with thrombocytopenia
4. Pregnant patients with type 2 diabetes

Primary outcomes:
measure: The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The percentage of patients examined by Fibroscan in each group with FIB4≥2.67
timeFrame: through study completion, an average of 1 year
measure: The hepatology clinic referral rate if FIB-4 ≥ 1.3 and <2.67 in individual groups
timeFrame: through study completion, an average of 1 year
measure: Incidence rate of liver cirrhosis in individual groups
timeFrame: through study completion, an average of 1 year
measure: The hepatology clinic referral rate of patients with FIB-4 <1.3 in individual groups
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine
name: Tung Hung Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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