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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
Select...
My liver enzyme (ALT) levels have been high in the last year.
Select...
I have been diagnosed with type 2 diabetes.

NAFLD-DM Trial Timeline

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
T2D medication management
2023
N/A
~10
diet/lifestyle support
2023
N/A
~10
NAFLD Education
2023
N/A
~10
clinically-indicated liver testing and care
2023
N/A
~10

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,381 Previous Clinical Trials
3,427,703 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
~6 spots leftby Jun 2025
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