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

Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; NAFLD
• Intervention / Treatment: Behavioral: NAFLD Education; Behavioral: diet/lifestyle support; Drug: T2D medication management; Diagnostic test: clinically-indicated liver testing and care

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anastasia-Stefania Alexopoulos, MD; Phone Number: 919 684 4005; Email: anastasia.alexopoulos@duke.edu
• Study Contact Backup: Name: Susanne Danus; Phone Number: 919 681 4453; Email: susanne.danus@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Healthcare System
      • Contact: Susanne Danus; Phone Number: 919 681 4453; Email: susanne.danus@duke.edu
      • Contact: Anastasia-Stefania Alexopoulos, MD; Phone Number: 919-684-4005; Email: anastasia.alexopoulos@duke.edu
      • Principal Investigator: Anastasia-Stefania Alexopoulos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by recruitment rate	We will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled	3months
Feasibility as measured by retention rate	We will assess retention rates: Patients enrolled / Patients completing study	3months
Feasibility as measured by visit completion rate	We will assess visit completion rates: Total study visits completed / Total study visits scheduled	3months
Feasibility of system-level NAFLD detection approach	Patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria. We will deem this approach feasible if detection rates are >70%.	Baseline
Acceptability of intervention by participants	We will calculate the mean and standard deviation of the Treatment Acceptability and Preferences (TAP);Minimum value = 0; Maximum value = 4; Higher score is a better outcome (ie more acceptable). We will define acceptable score as mean TAP ≥ 3.	3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Efficacy measured by the Managing Chronic Diseases (SEMCD) score	The SEMCD is a 6-item scale with a minimum value = 1; Maximum value = 10; Higher score is a better outcome (ie greater self-efficacy) Maximum value = 60, Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of >/=1.	Baseline, 3months
Change in Self-Efficacy measured by the Modified Health care Climate Questionnaire (HCCQ)	The HCCQ is a 5-item scale with a minimum value = 1; Maximum value = 5; Higher score is a better outcome (ie greater self-management) Will be measured by a change of >/=1 as being clinically significant.	Baseline, 3months
Change in mean hemoglobin A1c (HbA1c)	Change of >/= 0.5% will be deemed clinically significant	Baseline, 3months
Change in mean alanine aminotransferase (ALT) level	Change of >/= 5 IU/mL will be deemed clinically significant.	Baseline, 3months
Change in medication adherence	Change as measured by the Voils Non-adherence measure. Minimum value = 0; maximum value = 5. Higher score is worse outcome (ie more non-adherence). Will be measured by change of >/= 1.	Baseline, 3months
Change in Quality of Living as measured by the SF-12	The SF-12 is a 5-item scale with a minimum value = 0; Maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant.	Baseline, 3months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Anastasia-Stefania Alexopoulos, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Fatty Liver; Diabetes Mellitus; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Pro00113239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NA- IPD will not be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No