N/A
Completed N=10
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT05844137 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Feasibility as Measured by Recruitment Rate — 8; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Measured by Recruitment Rate |
8; 2 | — |
| PRIMARY Feasibility as Measured by Retention Rate |
10 | — |
| PRIMARY Feasibility as Measured by Visit Completion Rate |
30 | — |
| PRIMARY Feasibility of System-level NAFLD Detection Approach |
122 | — |
| PRIMARY Acceptability of Intervention by Participants |
3.98 | — |
| SECONDARY Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score |
0.4 | — |
| SECONDARY Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ) |
-0.1 | — |
| SECONDARY Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12) |
3.0 | — |
| SECONDARY Change in Mental Health Quality of Living as Measured by the SF-12 |
0.5 | — |
| SECONDARY Change in Mean Hemoglobin A1c (HbA1c) |
— | — |
| SECONDARY Change in Mean Alanine Aminotransferase (ALT) Level |
— | — |
| SECONDARY Number of Participants With Changes to Medications During the Study Period Measured by Chart Review |
5 | — |
| SECONDARY Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). |
7; 2; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05844137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.