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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevalence of presumed advanced NASH based on biochemical and FibroScan results

Secondary outcome measures

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

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)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

LMC Diabetes & Endocrinology Ltd.Lead Sponsor

16 Previous Clinical Trials

17,883 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study accepting volunteers under the age of sixty?

"The prerequisites for this trial require that participants be between 18 and 80 years old. Furthermore, there are 213 individual trials solely dedicated to those younger than 18 and 1,273 studies concerning individuals aged 65 or above."

Answered by AI

Is this research endeavor currently taking on volunteers?

"Data on clinicaltrials.gov indicates this medical experiment is still enrolling participants, having been posted at the start of August 2021 and updated later in the same month."

Answered by AI

How extensive is the current participant cohort for this trial?

"Truly. Clinicaltrials.gov records suggest that this investigation is recruiting individuals to take part in it, with the initial posting taking place on August 11th 2021 and an update having been made on August 25th 2021. The study requires 5000 volunteers from a single site."

Answered by AI

Who is eligible to enroll in this medical experiment?

"This research project seeks to enrol 5000 participants suffering from type 2 diabetes mellitus, each between 18 and 80 years old. Additionally, potential candidates must have a BMI greater than 25 kg/m2 or waist circumference of more than 102 cm in men and 88 cm in women. Lastly, all persons taking part need to sign an informed consent agreement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)

2021. "Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05029583.

All > Fatty Liver Disease > Type 2 Diabetes