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NCT05844137 · ClinicalTrials.gov registry record · NA
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT05844137 is a NA study that has completed, run by Duke University. The registered enrollment target is 10 participants.
The verdict
NCT05844137, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL NAFLD Education
- BEHAVIORAL diet/lifestyle support
- DRUG T2D medication management
- DIAGNOSTIC_TEST clinically-indicated liver testing and care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-09-18 |
| Est. Completion | 2024-01-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05844137
The ClinicalTrials.gov registry entry for NCT05844137 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which NAFLD Education is the first listed.
NCT05844137 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05844137 about?
NCT05844137 is a clinical study titled "Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes". 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-...
What is the current status of trial NCT05844137?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2023-09-18. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT05844137?
The interventions under investigation include: NAFLD Education (BEHAVIORAL), diet/lifestyle support (BEHAVIORAL), T2D medication management (DRUG), clinically-indicated liver testing and care (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05844137?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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