Type 2 DiabetesNCT06694974
Liver Fibrosis Assessment in Diabetic Patients
A study testing APP calculation for FIB-4 in people with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- APP calculation for FIB-4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Nov 2024to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients, regular follow-up in OPD every 3 months
- Age 35-65 (Because FIB-4 is not accurate in people with age <35 or > 65)
Who cannot join
- Patients are regularly follow the investigators at the liver clinic for liver disease
- Active malignancy
- Hematology disease with thrombocytopenia
- Pregnant patients with type 2 diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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).
- Being tested
- APP calculation for FIB-4, Standard Care (in control arm)
- Keywords
- Type 2 diabetes patients, metabolic dysfunction-associated steatotic liver disease
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP calculation for FIB-4Behavioural
the investigators plan to use the smartphone App for FIB-4 calculation and notify the patients.
Standard Care (in control arm)Behavioural
The standard group proceeds as regular practice
| Study group | Role | What they receive |
|---|---|---|
| FIB-4 APP group | Experimental | Not described Receives: Behavioral: APP calculation for FIB-4 |
| standard group | Other | Not described Receives: Behavioral: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3)
Number of patients with FIB-4 ≥ 2.67 being referred to hepatology clinic, divided by total number of patients with FIB-4 ≥ 2.67.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
The percentage of patients examined by Fibroscan in each group with FIB4≥2.67
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
Measured: through study completion, an average of 1 year
The hepatology clinic referral rate if FIB-4 ≥ 1.3 and <2.67 in individual groups
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
Measured: through study completion, an average of 1 year
Incidence rate of liver cirrhosis in individual groups
Patients diagnosed with liver cirrhosis clinically, divided by the total number of patients in the individual group
Measured: through study completion, an average of 1 year
The hepatology clinic referral rate of patients with FIB-4 <1.3 in individual groups
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start22 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tung Hung Su, MD, PhD, Principal investigator, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694974
- Sponsor's protocol ID
- 202408147RINA
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the patients' privacy information.
Publications
Zhang X, Yip TC, Wong GL, Leow WX, Liang LY, Lim LL, Li G, Ibrahim L, Lin H, Lai JCT, Chim AM, Chan HLY, Kong AP, Chan WK, Wong VW. Clinical care pathway to detect advanced liver disease in patients with type 2 diabetes through automated fibrosis score calculation and electronic reminder messages: a randomised controlled trial. Gut. 2023 Nov 24;72(12):2364-2371. doi: 10.1136/gutjnl-2023-330269.
PubMed 37549979Lazarus JV, Mark HE, Villota-Rivas M, Palayew A, Carrieri P, Colombo M, Ekstedt M, Esmat G, George J, Marchesini G, Novak K, Ocama P, Ratziu V, Razavi H, Romero-Gomez M, Silva M, Spearman CW, Tacke F, Tsochatzis EA, Yilmaz Y, Younossi ZM, Wong VW, Zelber-Sagi S, Cortez-Pinto H, Anstee QM; NAFLD policy review collaborators. The global NAFLD policy review and preparedness index: Are countries ready to address this silent public health challenge? J Hepatol. 2022 Apr;76(4):771-780. doi: 10.1016/j.jhep.2021.10.025. Epub 2021 Dec 9.
PubMed 34895743Younossi ZM, Ong JP, Takahashi H, Yilmaz Y, Eguc Hi Y, El Kassas M, Buti M, Diago M, Zheng MH, Fan JG, Yu ML, Wai-Sun Wong V, Alswat K, Chan WK, Mendez-Sanchez N, Burra P, Bugianesi E, Duseja AK, George J, Papatheodoridis GV, Saeed H, Castera L, Arrese M, Kugelmas M, Romero-Gomez M, Alqahtani S, Ziayee M, Lam B, Younossi I, Racila A, Henry L, Stepanova M; Global Nonalcoholic Steatohepatitis Council. A Global Survey of Physicians Knowledge About Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1456-e1468. doi: 10.1016/j.cgh.2021.06.048. Epub 2021 Jul 3.
PubMed 34229038Lomonaco R, Godinez Leiva E, Bril F, Shrestha S, Mansour L, Budd J, Portillo Romero J, Schmidt S, Chang KL, Samraj G, Malaty J, Huber K, Bedossa P, Kalavalapalli S, Marte J, Barb D, Poulton D, Fanous N, Cusi K. Advanced Liver Fibrosis Is Common in Patients With Type 2 Diabetes Followed in the Outpatient Setting: The Need for Systematic Screening. Diabetes Care. 2021 Feb;44(2):399-406. doi: 10.2337/dc20-1997. Epub 2020 Dec 21.
PubMed 33355256Lai LL, Wan Yusoff WNI, Vethakkan SR, Nik Mustapha NR, Mahadeva S, Chan WK. Screening for non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus using transient elastography. J Gastroenterol Hepatol. 2019 Aug;34(8):1396-1403. doi: 10.1111/jgh.14577. Epub 2019 Jan 21.
PubMed 30551263Kwok R, Choi KC, Wong GL, Zhang Y, Chan HL, Luk AO, Shu SS, Chan AW, Yeung MW, Chan JC, Kong AP, Wong VW. Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. Gut. 2016 Aug;65(8):1359-68. doi: 10.1136/gutjnl-2015-309265. Epub 2015 Apr 14.
PubMed 25873639American Diabetes Association Professional Practice Committee. 4. Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S52-S76. doi: 10.2337/dc24-S004.
PubMed 38078591Long MT, Noureddin M, Lim JK. AGA Clinical Practice Update: Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals: Expert Review. Gastroenterology. 2022 Sep;163(3):764-774.e1. doi: 10.1053/j.gastro.2022.06.023. Epub 2022 Jul 14.
PubMed 35842345Castera L, Cusi K. Diabetes and cirrhosis: Current concepts on diagnosis and management. Hepatology. 2023 Jun 1;77(6):2128-2146. doi: 10.1097/HEP.0000000000000263. Epub 2023 Jan 13.
PubMed 36631005Wattacheril JJ, Abdelmalek MF, Lim JK, Sanyal AJ. AGA Clinical Practice Update on the Role of Noninvasive Biomarkers in the Evaluation and Management of Nonalcoholic Fatty Liver Disease: Expert Review. Gastroenterology. 2023 Oct;165(4):1080-1088. doi: 10.1053/j.gastro.2023.06.013. Epub 2023 Aug 4.
PubMed 37542503