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

NCT05844137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-27

Study results available
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Summary

The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT \>/= 40 IU/mL in males, ALT \>/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse).

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

Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.

Conditions

Interventions

BEHAVIORAL

NAFLD Education

NAFLD Education

BEHAVIORAL

diet/lifestyle support

diet/lifestyle support

DRUG

T2D medication management

T2D medication management

DIAGNOSTIC_TEST

clinically-indicated liver testing and care

clinically-indicated liver testing and care

Sponsors & Collaborators

Principal Investigators

  • Anastasia-Stefania Alexopoulos, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-01-29
Completion
2024-01-29

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844137 on ClinicalTrials.gov