NCT06688149Completed
NASH Patient's Itinerary: Comparison of Strategies for Screening, Referring and Management of Diabetic Patients
Source: ClinicalTrials.gov · Last updated 14 Nov 2024
Brief summary (registry, in English)
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent, underdiagnosed, health system burden and impacts on quality of life including comorbidities in the affected population. Cost-effective strategies focusing on clinical pathways to detect and refer patients to care are needed. The aim of this study is to build a stepwise algorithm combining non-invasive freely available methods (FIB-4, NFS, HFS alone or combined) and vibration-controlled transient elastography (VCTE) in diabetic patients from primary care and endocrinology units.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 536 (actual)
- First submitted
- 30 Oct 2024
- Start date
- 31 Jan 2021
- Primary completion date
- 31 Jan 2023
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06688149
What you commit to
- Study type: Interventional
- Participants enrolled: 536
- From 31 Jan 2021 to the primary completion date, 31 Jan 2023
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of concomitant liver disease (i.e., viral or autoimmune hepatitis, HIV, drug-induced fatty liver, hemochromatosis, or Wilson's disease).
Other
- Significant alcohol intake (\>30 g daily for men and \>20g daily for women).
Who the study is looking for
- Age between 18 and 75.
- Type 2 Diabetes Mellitus. Patients will be considered as diabetic when: A1C ≥6.5% OR FPG ≥126 mg/dL OR 2-h PG ≥200 mg/dl during the OGTT OR anti-diabetic drug users.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| University Medical Center Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Hospital Universitario Virgen del Rocío de Sevilla Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Harokopio University of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.