Trial Summary
What is the purpose of this trial?The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.
Is Jardiance a promising drug for treating fatty liver disease in people with type 2 diabetes?Jardiance is considered a promising drug for treating fatty liver disease in people with type 2 diabetes because it addresses a common and serious health issue. Many people with type 2 diabetes also have fatty liver disease, which can lead to more severe liver problems. By using Jardiance, there is potential to improve liver health and reduce the risk of complications.246910
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for Jardiance in treating fatty liver disease in type 2 diabetes?The provided research does not directly address the safety data for Jardiance (empagliflozin) in treating fatty liver disease in type 2 diabetes. The studies focus on screening strategies for non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes, the association of NAFLD with other health risks, and the validation of clinical pathways for NAFLD. For specific safety data on Jardiance, clinical trial results or specific studies evaluating its use in NAFLD would be needed.237911
What data supports the idea that Jardiance for Fatty Liver Disease in Type 2 Diabetes is an effective drug?The available research does not provide specific data on Jardiance as an effective drug for treating Fatty Liver Disease in Type 2 Diabetes. Instead, it focuses on the importance of screening for the disease in patients with Type 2 Diabetes, as they are at high risk. The studies emphasize the need for early detection and management of the disease to prevent complications, but they do not mention Jardiance as a treatment option.13568
Eligibility Criteria
This trial is for adults aged 18-80 with Type 2 Diabetes and presumed advanced NASH (a type of liver disease). Participants must have a BMI over 25 or a large waist size, but can't join if they've had certain other liver diseases, alcohol abuse, are pregnant/breastfeeding, have language barriers, unstable diabetes conditions like recent hospitalization or dialysis, or an implanted electronic device.Inclusion Criteria
I am between 18 and 80 years old.
I have been diagnosed with type 2 diabetes.
My BMI is over 25, or my waist is larger than 102 cm (men) or 88 cm (women).
Exclusion Criteria
I have a history of liver disease or conditions as per my medical records.
Treatment Details
The study compares two ways to screen for advanced NASH in people with Type 2 Diabetes: one group will undergo physician-driven screening while the other will follow routine screening. The first phase is randomized and the second phase tracks patients over time in a registry.
2Treatment groups
Experimental Treatment
Active Control
Group I: routine screening groupExperimental Treatment1 Intervention
consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2)
Group II: physician-driven screening groupActive Control1 Intervention
consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1)
Find a clinic near you
Research locations nearbySelect from list below to view details:
LMC Diabetes & Endocrinology Ltd.Toronto, Canada
Loading ...
Who is running the clinical trial?
LMC Diabetes & Endocrinology Ltd.Lead Sponsor
References
Prognostic implication of liver histology in patients with nonalcoholic fatty liver disease in diabetes. [2022]Nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM) frequently coexist due to shared risk factors. Their rising prevalence parallels the growing epidemic of obesity and insulin resistance (IR). In patients with T2DM and biopsy-proven NAFLD, a significantly higher prevalence of nonalcoholic steatohepatitis (NASH) (63-87%), any fibrosis (22-60%), and advanced fibrosis (4-9%) is noted. Possible risk factors for more advanced liver disease include concomitant metabolic syndrome with three or more components, visceral obesity, older age, increased duration of diabetes, and family history of diabetes. Liver biopsy is strongly suggested in these patients. Cardiovascular disease (CVD) and malignancy are the leading causes of death in this population, but a growing body of evidence shows liver-related mortality as an important cause of death, including an increased rate of hepatocellular carcinoma (HCC) in diabetes. The presence of NAFLD in T2DM is also associated with increased overall mortality. We aim with this review to summarize the results from studies investigating NAFLD in T2DM and to outline the factors that predict more advanced liver histology as well as the impact of these hepatic changes on CVD, overall and liver-related mortality.
Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. [2022]Type 2 diabetes is an important risk factor for non-alcoholic fatty liver disease (NAFLD), but current guidelines provide conflicting recommendations on whether diabetic patients should be screened for NAFLD. We therefore studied the strategy of screening diabetic patients by FibroScan.
Non-invasive screening of diabetics in primary care for NAFLD and advanced fibrosis by MRI and MRE. [2022]Current guidelines do not recommend screening for non-alcoholic fatty liver disease (NAFLD) or advanced fibrosis. Patients with type 2 diabetes mellitus (T2DM) are known to be at increased risk for NAFLD and advanced fibrosis.
Screening strategies for nonalcoholic fatty liver disease in type 2 diabetes: Insights from NHANES 2005-2016. [2020]Nonalcoholic fatty liver disease (NAFLD) is prevalent in patients with type 2 diabetes mellitus (T2DM), but controversy exists on whether to screen and how to manage these patients in clinical practice. Here, we estimate the number of patients with T2DM and NAFLD in the United States that should be evaluated for advanced liver fibrosis according to proposed screening strategies.
NAFLD: Diagnostic Algorithms for Regulating Patient Fluxes. [2021]The global prevalence of NAFLD is estimated to be over 25% and it is already the leading cause of chronic liver disease in industrialized countries, as a consequence of the spread of obesity and metabolic syndrome. The prognosis of NAFLD is generally benign in the absence of fibrosis, but liver fibrosis rapidly progresses in 20% of the cases and can lead to cirrhosis and/or HCC. This review focuses on non-invasive fibrosis testing strategies for patients with NAFLD in order to increase the efficiency and effectiveness of diagnosis and care, regulating secondary care referral fluxes. An integrated management plan between primary care and secondary care with a defined algorithm of non-invasive testing to stratify the risk of NAFLD fibrosis is indispensable to increase the early diagnosis of fibrosis but also decrease unnecessary referrals.
Nonalcoholic Fatty Liver Disease Screening in Type 2 Diabetes Mellitus Patients in the Primary Care Setting. [2023]Nonalcoholic fatty liver disease (NAFLD) is a major public health problem worldwide and the most common chronic liver disease. NAFLD currently affects approximately one in every four people in the United States, and its global burden is expected to rise in the next decades. Despite being a prevalent disease in the general population, only a minority of patients with NAFLD will develop nonalcoholic steatohepatitis (NASH) with advanced liver fibrosis (stage 3-4 fibrosis) and liver-related complications. Certain populations, such as patients with type 2 diabetes mellitus (T2DM), are recognized to be at the highest risk for developing NASH and advanced fibrosis. Both the American Diabetes Association and the European Association for the Study of Diabetes recommend screening of all T2DM for NAFLD. Incorporating a simple noninvasive algorithm into the existing diabetic care checklists in the primary care practice or diabetologist's office would efficiently identify patients at high risk who should be referred to specialists. The proposed algorithm involves a first-step annual fibrosis-4 score (FIB-4) followed by vibration-controlled transient elastography (VCTE) for those with indeterminate or high-risk score (FIB-4 ≥1.3). Patients at low-risk (FIB-4 <1.3 or VCTE <8 kPa) can be followed up by primary care providers for lifestyle changes and yearly calculation of FIB-4, while patients at high risk (FIB-4 ≥1.3 and VCTE ≥8 kPa) should be referred to a liver-specialized center. Conclusion: Patients with T2DM or prediabetes should be screened for NASH and advanced fibrosis. The proposed simple algorithm can be easily incorporated into the existing workflow in the primary care or diabetology clinic to identify patients at high risk for NASH and advanced fibrosis who should be referred to liver specialists.
Non-alcoholic fatty liver disease: a multisystem disease requiring a multidisciplinary and holistic approach. [2021]Non-alcoholic fatty liver disease (NAFLD) is a public health problem worldwide. This narrative Review provides an overview of the current literature to support the notion that NAFLD is a multisystem disease. Convincing evidence shows a strong association between NAFLD and the risk of developing multiple extrahepatic complications such as type 2 diabetes, cardiovascular disease (ie, the predominant cause of mortality in people with NAFLD), chronic kidney disease, and some types of extrahepatic malignancies. The magnitude of this risk parallels the severity of NAFLD (especially the stage of liver fibrosis). There are probably multiple underlying mechanisms by which NAFLD might increase the risk of cardiovascular disease, type 2 diabetes, and extrahepatic complications. Addressing the growing burden of NAFLD will require setting up a multidisciplinary working group and framework to progress and embrace novel collaborative ways of working to deliver holistic, person-centred care and management of people with NAFLD.
Screening for nonalcoholic fatty liver disease-when, who and how? [2021]Nonalcoholic fatty liver disease (NAFLD) is becoming a frequent liver disease, especially in patients with metabolic syndrome and especially in Western countries. Complications of NAFLD comprise progressive fibrosis, cirrhosis and hepatocellular carcinoma. NAFLD also represents an independent risk factor for cardiovascular disease, extrahepatic neoplasia and other organ damage, such as renal insufficiency. Given the epidemiological importance of the disease, new developments in specific treatment of the disease and the wide availability of noninvasive techniques in estimating steatosis and fibrosis, NAFLD should be subject to screening programs, at least in countries with a high prevalence of the disease. The review discusses prerequisites for screening, cost-effectiveness, current guideline recommendations, suitability of techniques for screening and propositions for the following questions: Who should be screened? Who should perform screening? How should screening be performed? It is time for a screening program in patients at risk for NAFLD.
Risk of liver-related events by age and diabetes duration in patients with diabetes and nonalcoholic fatty liver disease. [2022]Several guidelines recommend screening for NAFLD in patients with type 2 diabetes (T2D). We aimed to determine if there is a threshold of age and duration of T2D for liver-related event development to guide screening strategies.
A Cross-sectional Real-life Study of the Prevalence, Severity, and Determinants of Metabolic Dysfunction-associated Fatty Liver Disease in Type 2 Diabetes Patients. [2023]Most data on liver assessment in type 2 diabetes mellitus (T2DM) patients are from retrospective cohorts with selection bias. We aimed at appraising the feasibility, results, and benefits of an outpatient systematic noninvasive screening for metabolic dysfunction-associated fatty liver disease (MAFLD) severity and determinants in T2DM patients.
Validation of AGA clinical care pathway and AASLD practice guidance for nonalcoholic fatty liver disease in a prospective cohort of patients with type 2 diabetes. [2023]Recently, the American Gastroenterological Association (AGA) and American Association for the Study of Liver Diseases (AASLD) developed clinical pathways to evaluate populations at high-risk for nonalcoholic fatty liver disease (NAFLD). We assessed the diagnostic performance of the new guidance in a well-phenotyped cohort of patients with Type 2 diabetes mellitus (T2DM).