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

NCT ID: NCT05844137

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-01-29

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evidence-based care of NAFLD in T2D

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

Group Type EXPERIMENTAL

NAFLD Education

Intervention Type BEHAVIORAL

NAFLD Education

diet/lifestyle support

Intervention Type BEHAVIORAL

diet/lifestyle support

T2D medication management

Intervention Type DRUG

T2D medication management

clinically-indicated liver testing and care

Intervention Type DIAGNOSTIC_TEST

clinically-indicated liver testing and care

Interventions

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NAFLD Education

NAFLD Education

Intervention Type BEHAVIORAL

diet/lifestyle support

diet/lifestyle support

Intervention Type BEHAVIORAL

T2D medication management

T2D medication management

Intervention Type DRUG

clinically-indicated liver testing and care

clinically-indicated liver testing and care

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* People who identify as either: Latino/Latina/Hispanic ethnicity and/or Black or African American race
* People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx.
* 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

Exclusion Criteria

* People with hepatitis B or C infection
* People with known alcohol overuse
* People with current use of chemotherapy or other drugs known to affect liver function
* People who have not been seen by a DUHS Primary Care Physician (PCP) or Endocrinologist in the preceding year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anastasia-Stefania Alexopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Healthcare System

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00113239

Identifier Type: -

Identifier Source: org_study_id