Liver Fibrosis Assessment in Diabetic Patients

NCT06694974 | Not Yet Recruiting

• 1 other identifier: 202408147RINA
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Type 2 diabetes patients; metabolic dysfunction-associated steatotic liver disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  through study completion, an average of 1 year

• The hepatology clinic referral rate if FIB-4 ≥ 1.3 and <2.67 in individual groups

  through study completion, an average of 1 year

• Incidence rate of liver cirrhosis in individual groups

  through study completion, an average of 1 year

• The hepatology clinic referral rate of patients with FIB-4 <1.3 in individual groups

  through study completion, an average of 1 year

Study Arms (2)

FIB-4 APP group

EXPERIMENTAL

Behavioral: APP calculation for FIB-4

standard group

OTHER

Behavioral: Standard Care (in control arm)

Interventions

APP calculation for FIB-4 BEHAVIORAL

the investigators plan to use the smartphone App for FIB-4 calculation and notify the patients.

FIB-4 APP group

Standard Care (in control arm) BEHAVIORAL

The standard group proceeds as regular practice

standard group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 37549979 BACKGROUND

• Lazarus 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.

  PMID: 34895743 BACKGROUND

• Younossi 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.

  PMID: 34229038 BACKGROUND

• Lomonaco 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.

  PMID: 33355256 BACKGROUND

• Lai 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.

  PMID: 30551263 BACKGROUND

• Kwok 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.

  PMID: 25873639 BACKGROUND

• American 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.

  PMID: 38078591 BACKGROUND

• Long 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.

  PMID: 35842345 BACKGROUND

• Castera 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.

  PMID: 36631005 BACKGROUND

• Wattacheril 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.

  PMID: 37542503 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tung Hung Su, MD, PhD

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tung Hung Su, MD, PhD

CONTACT

886-972651694; tunghungsu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 19, 2024
• Study Start: November 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)