Liver Fibrosis Assessment in Diabetic Patients

November 19, 2024 updated by: National Taiwan University Hospital

A Randomized Controlled Trial for Liver Fibrosis Assessment in Diabetic Patients

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIB-4 APP group
Behavioral: APP calculation for FIB-4
the investigators plan to use the smartphone App for FIB-4 calculation and notify the patients.
Other: standard group
Behavioral: Standard Care (in control arm)
The standard group proceeds as regular practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3)
Time Frame: through study completion, an average of 1 year
Number of patients with FIB-4 ≥ 2.67 being referred to hepatology clinic, divided by total number of patients with FIB-4 ≥ 2.67.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patients examined by Fibroscan in each group with FIB4≥2.67
Time Frame: through study completion, an average of 1 year
The number of patients with a FIB-4 ≥ 2.67 and received the fibroscan test, divided by the total number of patients with a FIB-4 ≥ 2.67
through study completion, an average of 1 year
The hepatology clinic referral rate if FIB-4 ≥ 1.3 and <2.67 in individual groups
Time Frame: through study completion, an average of 1 year
The number of patients with FIB-4 ≥ 1.3 and <2.67 and referred to the hepatology clinic, divided by the total number of patients with FIB-4 ≥ 1.3 and <2.67
through study completion, an average of 1 year
Incidence rate of liver cirrhosis in individual groups
Time Frame: through study completion, an average of 1 year
Patients diagnosed with liver cirrhosis clinically, divided by the total number of patients in the individual group
through study completion, an average of 1 year
The hepatology clinic referral rate of patients with FIB-4 <1.3 in individual groups
Time Frame: through study completion, an average of 1 year
The number of patients with FIB-4 <1.3 and referred to hepatology clinic, divided by the total number of patients with FIB-4 <1.3
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Tung Hung Su, MD, PhD, Department of Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 22, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202408147RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the patients' privacy information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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