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Jardiance for Fatty Liver Disease in Type 2 Diabetes

N/A
Recruiting
Led By Harpreet Bajaj, MD
Research Sponsored by LMC Diabetes & Endocrinology Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 80 years
Clinical diagnosis of T2D
Must not have
Known history of biopsy-proven NAFLD or NASH, hepatitis B, hepatitis C, HIV, liver cirrhosis, hemochromatosis, drug-induced hepatitis, alcohol-related or autoimmune hepatic disease, history of hepatic decompensation, solid organ transplant, or primary liver cancer, based on electronic medical record
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new treatment for diabetes, called Jardiance, can also help treat patients with a fatty liver disease called NASH.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on screening methods rather than medications or treatments, there aren't direct side effects from interventions. However, procedures involved in screenings may cause discomfort or minor risks associated with medical tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have been diagnosed with type 2 diabetes.
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My BMI is over 25, or my waist is larger than 102 cm (men) or 88 cm (women).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of liver disease or conditions as per my medical records.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of presumed advanced NASH based on biochemical and FibroScan results
Secondary study objectives
Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score
Alcohol consumption by study arm - drinks per day
Alcohol consumption by study arm - drinks per week
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

LMC Diabetes & Endocrinology Ltd.Lead Sponsor
16 Previous Clinical Trials
17,883 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
4,000 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Harpreet Bajaj, MDPrincipal InvestigatorLMC Diabetes & Endocrinology Ltd.
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

routine screening Clinical Trial Eligibility Overview. Trial Name: NCT05029583 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: physician-driven screening group, routine screening group
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: routine screening Highlights & Side Effects. Trial Name: NCT05029583 — N/A
routine screening 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029583 — N/A
~918 spots leftby Oct 2025
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