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Comprehensive Care for NAFLD in Type 2 Diabetes Patients (NAFLD-DM Trial)

N/A

Waitlist Available

Led By Anastasia-Stefania Alexopoulos, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with elevated serum alanine aminotransferase (ALT) within Duke University Healthcare System (DUHS). Elevated ALT will be defined as having at least two ALT ≥40 IU/mL in males or ≥31 IU/mL in females in the preceding 12 months

People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3months

Awards & highlights

NAFLD-DM Trial Summary

This trial assesses the feasibility and acceptability of an intervention to improve care for NAFLD in Latinx/Black T2D patients: educ, diet/lifestyle support, med management, liver testing. Minimal risk, expected risks not exceeding usual care.

Who is the study for?

This trial is for Latinx and Black patients within the Duke University Healthcare system who have type 2 diabetes and non-alcoholic fatty liver disease (NAFLD), indicated by elevated liver enzymes. It's not open to those with hepatitis, current chemotherapy or drugs affecting liver function, no recent DUHS doctor visits, or known alcohol overuse.Check my eligibility

What is being tested?

The study tests an intervention including NAFLD education, diet/lifestyle support, T2D medication management, and necessary liver care. The goal is to see if this approach is workable and well-received among participants for better detection and treatment of NAFLD in diabetic patients.See study design

What are the potential side effects?

Since the interventions involve education, lifestyle changes, and standard medical care rather than new medications or procedures, side effects are expected to be minimal and not exceed usual healthcare risks.

NAFLD-DM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver enzyme (ALT) levels have been high in the last year.

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I have been diagnosed with type 2 diabetes.

NAFLD-DM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Acceptability of intervention by participants

Feasibility as measured by recruitment rate

Feasibility as measured by retention rate

+2 more

Secondary outcome measures

Change in Quality of Living as measured by the SF-12

Change in Self-Efficacy measured by the Managing Chronic Diseases (SEMCD) score

Change in Self-Efficacy measured by the Modified Health care Climate Questionnaire (HCCQ)

+3 more

NAFLD-DM Trial Design

1Treatment groups

Experimental Treatment

Group I: Evidence-based care of NAFLD in T2DExperimental Treatment4 Interventions

Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

diet/lifestyle support

2023

N/A

~10

T2D medication management

2023

N/A

~10

NAFLD Education

2023

N/A

~10

clinically-indicated liver testing and care

2023

N/A

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,059 Total Patients Enrolled

14 Trials studying Diabetes

35,560 Patients Enrolled for Diabetes

Anastasia-Stefania Alexopoulos, MDPrincipal InvestigatorDuke University

Media Library

Evidence-based care of NAFLD in T2D Clinical Trial Eligibility Overview. Trial Name: NCT05844137 — N/A

Diabetes Research Study Groups: Evidence-based care of NAFLD in T2D

Diabetes Clinical Trial 2023: Evidence-based care of NAFLD in T2D Highlights & Side Effects. Trial Name: NCT05844137 — N/A

Evidence-based care of NAFLD in T2D 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844137 — N/A

Frequently Asked Questions

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

Is enrollment still an option for this investigation?

"Per the information on clinicaltrials.gov, this specific trial is not currently recruiting patients. It was initially published on August 1st 2023 and its last update occurred on April 25th 2023. However, there are presently 1405 other studies that are actively taking partcipants in their research efforts."

Answered by AI

What are the desired outcomes of this experiment?

"The main objective of this 3-month clinical study is to evaluate feasibility as measured by retention rate. Secondary outcomes include change in patient self-efficacy, which will be monitored using the Modified Health Care Climate Questionnaire (HCCQ), and mean hemoglobin A1c levels, with a clinically significant shift defined as greater than 0.5%. Lastly, quality of life will be assessed via the SF-12 scale; an increase beyond 10 points indicates noteworthy improvement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes

2023. "Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844137.