None listed
Conditions
Brief summary
The overall objective of the study is to develop and implement a practical pathway (NAFLD-RRR pathway) for optimal care of NAFLD in “high-risk” patients with T2D. The most important predictor of mortality in NAFLD is the extent of liver fibrosis as these patients are at risk of developing cirrhosis and its complications, including hepatocellular carcinoma (HCC). People with T2D have a high prevalence of NAFLD (40–70%), and are more likely to develop advanced fibrosis/cirrhosis and HCC. This study will use transient elastography with FibroScan as a screening and risk stratification tool for NAFLD in people attending diabetes clinics. The test allows measurement of the controlled attenuation parameter (CAP), which assesses the presence and level of hepatic steatosis, at the same time as evaluating liver stiffness to determine the presence or absence of advanced fibrosis. A referral pathway will be developed to facilitate patient access to required services. Individuals at low risk of advanced fibrosis will be managed in primary care, with a focus on healthy lifestyle and weight reduction and minimizing cardiovascular risk. In contrast, patients at risk of advanced fibrosis will be referred to secondary care for investigation of liver disease and management of advanced fibrosis with surveillance for HCC and liver decompensation. It is expected that more patients will be diagnosed with “high-risk” NAFLD than in usual diabetes care, and that a higher proportion of NAFLD referrals to Hepatology clinics will have clinically significant fibrosis. We anticipate that the study will produce new evidence about the economic benefits of a NAFLD detection/risk stratification pathway in patients with type 2 diabetes. We anticipate that patients with NAFLD will have a high rate of unmet needs related to lifestyle changes and practical and physical needs, and that identifying these needs will permit us to tailor strategies to promote patient-centred care and facilitate timely interventions or referral to appropriate support services.
Interventions
This is a prospective study to identify and risk-stratify nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes (T2D). Sequential participants will be recruited to the NAFLD-RRR model of care, and then followed for up to 10 years to monitor their health outcomes. The detection of patients with NAFLD ± advanced fibrosis and the surveillance for hepatocellular carcinoma (HCC) among “high-risk” patients will be compared to a historical sample of patients receiving “usual care”. Th
This is a prospective study to identify and risk-stratify nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes (T2D). Sequential participants will be recruited to the NAFLD-RRR model of care, and then followed for up to 10 years to monitor their health outcomes. The detection of patients with NAFLD ± advanced fibrosis and the surveillance for hepatocellular carcinoma (HCC) among “high-risk” patients will be compared to a historical sample of patients receiving “usual care”. The study will be conducted by a study nurse and liver fellow/student in diabetes clinics in addition to usual care (diabetes specialist review). The starting event is a patient scheduled for consultation in a Diabetes clinic. The study nurse will review the clinic list for each Diabetes clinic and briefly review the patient referral letter or clinic notes to identify patients that meet exclusion criteria. Scheduled patients will be invited to be screened for NAFLD when they attend a Diabetes clinic appointment, using FibroScan to assess steatosis (CAP score) and liver fibrosis (liver stiffness measurement, LSM). The invitation and assessment will be made by a specialist study nurse and/or liver fellow. The NAFLD screening assessment, including FibroScan and additional blood tests are anticipated to take 30 minutes to complete. At the FibroScan assessment the nurse and/or liver fellow will also assess: • Girth, alcohol consumption (using a brief AUDIT), and simple algorithms (FIB-4 and NAFLD fibrosis score) using recent routine blood test results. • A fasting blood test (up to 30ml) may be arranged for research purposes (this could be done when the diabetes doctor asks for a fasting blood test). • If relevant blood tests are not available within the last 6 months, the liver nurse will arrange blood tests (E/LFTs and FBC). Results will be followed up by liver fellow. • If liver enzymes are abnormal or LSM >/=8 kPa, additional blood tests (iron studies, hepatitis C and B serology, ANA, smooth muscle Ab, antimitochondrial Ab, anti-TTG) will be arranged. Results will be followed up by liver fellow. The study nurse will complete a template letter with the results of the FibroScan that will be sent directly to the Diabetes specialist with the patient after the procedure. A letter will also be sent to the patient’s GP and a copy of the FibroScan report will be scanned into the patient’s electronic medical record (iEMR). These templates will be designed specifically for the study. The patient will be diagnosed with NAFLD on the basis of the FibroScan CAP score (CAP score >/=248 dB considered as likely steatosis) and stratified to low or high risk of clinically significant fibrosis on the basis of the FibroScan liver stiffness measurement (LSM). No NAFLD: Participants with CAP score <248 dB and LSM<8 kPa will be classified as “no NAFLD”. A letter (with a copy to iEMR) will be sent to the patient’s GP and diabetes specialist advising a repeat FibroScan or liver ultrasound in 3-5 years if appropriate, to screen for development of NAFLD. NAFLD with Low risk of clinically significant fibrosis: Participants with CAP score >/=248 dB and low FibroScan score (LSM < 8.0 kPa) will be classified as ‘Low Risk’. A letter (with a copy to iEMR) will be sent to the patient’s GP and diabetes specialist advising a repeat FibroScan in 2-3 years if appropriate, to assess for development of clinically significant fibrosis. NAFLD with High risk of clinically significant fibrosis: Participants with CAP score >/=248 dB and elevated FibroScan score (LSM >/=8.0 kPa) will be classified as ‘High Risk’. The Liver Nurse will advise patient (and GP and diabetes specialist via letter, along with a copy to iEMR) that Hepatology referral recommended and arrange Hepatology Clinic consultation. Participants with a low CAP score and elevated LSM will also require Hepatology referral for further evaluation of possible clinically significant fibrosis. The recommendations will be provided in the summary letter to the GP and diabetes specialist which will be designed specifically for this study. The letter will contain for each patient the results of their FibroScan with a CAP score and LSM. It will also contain a summary of the recommendations and will have a standard format for each category of: no NAFLD, NAFLD with Low risk of clinically significant fibrosis, NAFLD with High risk of clinically significant fibrosis. If advanced fibrosis is confirmed in the secondary care hepatology clinic, the patient may be offered ongoing hepatology follow-up that may involve HCC and variceal surveillance programs. For all patients with NAFLD, the letter to the GP and diabetes specialist will provide recommendations regarding management of NAFLD with ongoing assessment and management of cardiometabolic risk factors and lifestyle intervention with consideration of referral to a dietician, exercise physiologist and psychologist for assistance with weight management and increased physical activity.
Sponsors
PA Hospital Foundation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Referred to a Diabetes Clinic for management of type 2 diabetes • Aged >/=18 years • Understand the consent procedures and give their full consent . • Consent to access their Queensland Health, primary care and Medicare Benefits Schedule (MBS)/Pharmaceutical Benefits Schedule (PBS) data.
Exclusion criteria
Are pregnant. Have advanced cardiac disease or another terminal illness. NESB and interpreter not available
Outcome results
None listed