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

Diabetes Mellitus Clinical Trial

— NAFLD-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05844137
• Other study ID #: Pro00113239
• Status: Completed
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• NAFLD Education
NAFLD Education
• 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

Locations

Country	Name	City	State
United States	Duke University Healthcare System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by recruitment rate	We will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled	3months
Primary	Feasibility as measured by retention rate	We will assess retention rates: Patients enrolled / Patients completing study	3months
Primary	Feasibility as measured by visit completion rate	We will assess visit completion rates: Total study visits completed / Total study visits scheduled	3months
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in mean hemoglobin A1c (HbA1c)	Change of >/= 0.5% will be deemed clinically significant	Baseline, 3months
Secondary	Change in mean alanine aminotransferase (ALT) level	Change of >/= 5 IU/mL will be deemed clinically significant.	Baseline, 3months
Secondary	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