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N/A N=1,061 Randomized Triple-blind Screening

Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages

Fatty Liver, Nonalcoholic · Diabetes Mellitus, Type 2

Enrolled (actual)
1,061
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Action on Suspected Advanced Liver Fibrosis — 55; 4 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Simple fibrosis scores and electronic reminder messages (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Chinese University of Hong Kong
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Action on Suspected Advanced Liver Fibrosis
55; 4
SECONDARY
Referral for Specialist Care
57; 6
SECONDARY
Inappropriate Referral for Specialist Care
1; 2
SECONDARY
Confirmed Diagnosis of Advanced Liver Fibrosis
11; 1

Summary

Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide and is a major cause of cirrhosis and liver cancer in Western countries. Because of its close association with obesity and diabetes, most patients are seen by primary care physicians and endocrinologists rather than hepatologists. Previous studies have shown that NAFLD is under-recognized outside specialist settings. As a result, many patients are undiagnosed and not receiving specific treatments. With this background, we aim to test the hypothesis that the use of simple fibrosis scores as part of a diabetes complications screening program followed by electronic reminder messages is more effective than usual care in prompting physicians to correctly identify patients with suspected NAFLD and advanced liver fibrosis for specialist referral or further liver assessment. Our secondary aim is to test the hypothesis that the use of fibrosis scores and electronic reminder messages can increase the number of patients with confirmed diagnosis of advanced liver fibrosis.

Eligibility Criteria

Inclusion Criteria

  • Age 18-70 years
  • Having type 2 diabetes
  • Provided informed written consent

Exclusion Criteria

  • Type 1 diabetes
  • Already receiving specialist care by gastroenterologists or hepatologists
  • Current or past history of hepatocellular carcinoma or liver decompensation
  • Active malignancies other than hepatocellular carcinoma, unless in complete remission for more than 5 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04241575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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