NCT05844137

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• NAFLD
• Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2023-05-06
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

1 site across 1 country: United States