Jardiance for Fatty Liver Disease in Type 2 Diabetes

Overseen By Karri Venn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LMC Diabetes & Endocrinology Ltd.

Disqualifiers: Liver disease, Alcohol abuse, Unstable T2D, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new screening methods for fatty liver disease in people with type 2 diabetes. Participants will receive either a physician-driven screening or routine screening to determine which method more effectively detects the condition. Suitable candidates should have type 2 diabetes and a higher body weight or waist size. This trial benefits those interested in learning more about their liver health while managing diabetes. Additionally, the trial will assess the use of Jardiance, a medication, for its potential benefits in managing fatty liver disease in this population. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve screening methods for fatty liver disease in people with type 2 diabetes.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these screening strategies are safe for patients with Type 2 Diabetes?

Research shows that Jardiance, the treatment under study, has FDA approval for managing type 2 diabetes, indicating thorough safety testing in people with diabetes.

Studies have generally found Jardiance to be well-tolerated. Most patients report mild side effects, such as increased urination or thirst. Serious side effects are rare but may include dehydration or low blood sugar, particularly when combined with other diabetes medications.

Although specific information on Jardiance for treating fatty liver disease (NASH) in people with type 2 diabetes is limited, its existing approval supports its safety in humans.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to screen for fatty liver disease in people with Type 2 diabetes. Unlike the usual one-size-fits-all approach, this trial compares physician-driven screening to routine screening, allowing doctors to tailor screening strategies based on specific patient needs. This could lead to earlier detection and more personalized care, potentially improving outcomes by catching the disease at a more manageable stage. By refining these screening methods, the trial aims to enhance the overall management of fatty liver disease in diabetes patients, potentially leading to better health outcomes.

What evidence suggests that this trial's screening strategies could be effective for fatty liver disease in type 2 diabetes?

Studies have shown that Jardiance (empagliflozin) can improve health for people with type 2 diabetes (T2D). It helps control blood sugar levels and is linked to weight loss and reduced liver fat. Research suggests that Jardiance may aid in managing fatty liver disease, common in people with T2D, by reducing liver fat buildup. This is crucial for individuals with NASH, a type of liver disease. Although specific data on NASH is limited, the drug's effects on liver fat and overall health in T2D patients appear promising. In this trial, participants will be divided into two groups: the physician-driven screening group and the routine screening group, to evaluate different screening strategies for NASH in T2D patients.

Who Is on the Research Team?

Harpreet Bajaj

Principal Investigator

LMC Diabetes & Endocrinology Ltd.

Are You a Good Fit for This Trial?

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 have been diagnosed with type 2 diabetes.

Informed consent

My BMI is over 25, or my waist is larger than 102 cm (men) or 88 cm (women).

Exclusion Criteria

Pregnancy/lactation

I have type 2 diabetes and have not been hospitalized in the last 3 months.

You have a history of regularly drinking a lot of alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Screening Intervention

Participants undergo biochemical screening and FibroScans if biochemical cut-offs are met

3 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after screening interventions

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• physician-driven screening
• routine screening

Trial Overview 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.

How Is the Trial Designed?

Group I: routine screening group Experimental Treatment 1 Intervention

consists of 4 clusters randomized into Group 1 (includes different clinic sites from Group 2)

Group II: physician-driven screening group Active Control 1 Intervention

consists of 4 clusters randomized into Group 2 (includes different clinic sites from Group 1)

Who Is Running the Clinical Trial?

LMC Diabetes & Endocrinology Ltd.

Lead Sponsor

Trials

19

Recruited

23,300+

Published Research Related to This Trial

Nonalcoholic fatty liver disease (NAFLD) is increasingly common, particularly among individuals with metabolic syndrome, and poses serious health risks including liver fibrosis, cirrhosis, and cardiovascular disease.

The review emphasizes the need for screening programs in high-prevalence areas, discussing the effectiveness and methods for screening, as well as who should be targeted and responsible for these screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for nonalcoholic fatty liver disease-when, who and how? Dietrich, CG., Rau, M., Geier, A.[2021]

Nonalcoholic fatty liver disease (NAFLD) affects about 25% of people in the U.S., with certain groups, like those with type 2 diabetes, at higher risk for developing more severe liver conditions like nonalcoholic steatohepatitis (NASH).

A proposed screening algorithm using the fibrosis-4 score (FIB-4) and vibration-controlled transient elastography (VCTE) can effectively identify high-risk patients for NASH, allowing for timely referrals to specialists and better management of liver health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonalcoholic Fatty Liver Disease Screening in Type 2 Diabetes Mellitus Patients in the Primary Care Setting. Vieira Barbosa, J., Lai, M.[2023]

Non-alcoholic fatty liver disease (NAFLD) affects over 25% of the global population and is the leading cause of chronic liver disease, often linked to obesity and metabolic syndrome.

Implementing non-invasive fibrosis testing strategies can improve early diagnosis of liver fibrosis in NAFLD patients, helping to manage referrals between primary and secondary care more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAFLD: Diagnostic Algorithms for Regulating Patient Fluxes. Pallini, G., Tsochatzis, EA.[2021]

Patients with type 2 diabetes mellitus (T2DM) and biopsy-proven nonalcoholic fatty liver disease (NAFLD) have a high prevalence of nonalcoholic steatohepatitis (NASH) and fibrosis, with significant risk factors including metabolic syndrome, visceral obesity, and older age.

The presence of NAFLD in T2DM is linked to increased overall mortality and liver-related deaths, highlighting the importance of liver health monitoring in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic implication of liver histology in patients with nonalcoholic fatty liver disease in diabetes. Doycheva, I., Patel, N., Peterson, M., et al.[2022]

In a study of 100 patients with type 2 diabetes, 65% were found to have non-alcoholic fatty liver disease (NAFLD) and 7.1% had advanced fibrosis, highlighting the high prevalence of these conditions in this population.

The use of non-invasive MRI techniques to screen for NAFLD and advanced fibrosis in diabetic patients is feasible, suggesting that such screening could be beneficial in primary care settings, pending further validation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive screening of diabetics in primary care for NAFLD and advanced fibrosis by MRI and MRE. Doycheva, I., Cui, J., Nguyen, P., et al.[2022]

Citations