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

Duke University

Status: Completed

Conditions: Diabetes Mellitus; NAFLD

Treatments: Diagnostic Test: clinically-indicated liver testing and care; Drug: T2D medication management; Behavioral: NAFLD Education; Behavioral: diet/lifestyle support

Study type: Interventional

Funder types: Other

Identifiers

NCT05844137

Pro00113239

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Evidence-based care of NAFLD in T2D

Experimental group

Description:

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

Treatment:

Behavioral: diet/lifestyle support

Behavioral: NAFLD Education

Drug: T2D medication management

Diagnostic Test: clinically-indicated liver testing and care