Clinical trial NCT05844137: Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
Official title: Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Diabetes Mellitus
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as Measured by Recruitment Rate
timeFrame: 3 months
measure: Feasibility as Measured by Retention Rate
timeFrame: 3months
measure: Feasibility as Measured by Visit Completion Rate
timeFrame: 3months
measure: Feasibility of System-level NAFLD Detection Approach
timeFrame: Baseline
measure: Acceptability of Intervention by Participants
timeFrame: 3months
Secondary outcomes:
measure: Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score
timeFrame: Baseline, 3months
measure: Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)
timeFrame: Baseline, 3months
measure: Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)
timeFrame: Baseline, 3months
measure: Change in Mental Health Quality of Living as Measured by the SF-12
timeFrame: Baseline, 3months
measure: Change in Mean Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 3months
measure: Change in Mean Alanine Aminotransferase (ALT) Level
timeFrame: Baseline, 3months
measure: Number of Participants With Changes to Medications During the Study Period Measured by Chart Review
timeFrame: baseline, 3 months
measure: Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging).
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Healthcare System
state: North Carolina
Study officials:
affiliation: Duke University
name: Anastasia-Stefania Alexopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: