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?

The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.

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 data supports the effectiveness of the drug Jardiance for treating fatty liver disease in patients with type 2 diabetes?

The research highlights the importance of screening for nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes, as they are at higher risk for developing more severe liver conditions. While the studies do not directly address Jardiance, they emphasize the need for effective management strategies in this population, which may include medications like Jardiance that are used to manage diabetes and potentially impact liver health. ^{1 2 3 4 5}

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

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]

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]

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]

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]

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]

Citations

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

NAFLD: Diagnostic Algorithms for Regulating Patient Fluxes. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nonalcoholic Fatty Liver Disease Screening in Type 2 Diabetes Mellitus Patients in the Primary Care Setting. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Screening for nonalcoholic fatty liver disease-when, who and how? [2021]

4. England pubmed.ncbi.nlm.nih.gov

Non-invasive screening of diabetics in primary care for NAFLD and advanced fibrosis by MRI and MRE. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prognostic implication of liver histology in patients with nonalcoholic fatty liver disease in diabetes. [2022]