Jardiance for Fatty Liver Disease in Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Harpreet Bajaj

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: LMC Diabetes & Endocrinology Ltd.

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

No Placebo Group

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.

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}

Research Team

Harpreet Bajaj

Principal Investigator

LMC Diabetes & Endocrinology Ltd.

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.

Informed consent

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.

Trial Timeline

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)

Treatment Details

Interventions

• physician-driven screening (Behavioural Intervention)
• routine screening (Behavioural Intervention)

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.

Participant Groups

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

LMC Diabetes & Endocrinology Ltd. Toronto, Canada

Who Is Running the Clinical Trial?

LMC Diabetes & Endocrinology Ltd.

Lead Sponsor

Trials

19

Patients Recruited

23,300+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

References

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]