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NASH Patient's Itinerary: Comparison of Strategies for Screening, Referring and Management of Diabetic Patients

NCT06688149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2024-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

DIAGNOSTIC_TEST

Derivation algorithms

Derivation algorithm based on non-invasive methods, to standardise the continuum of care for diabetic patients with NAFLD from primary care and endocrinology settings to NAFLD specialised units (NSU)

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Barcelona Institute for Global Health

    collaborator OTHER

  • Harokopio University

    collaborator OTHER

  • University Medical Center Mainz

    collaborator OTHER

  • University Düsseldorf

    collaborator OTHER

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Manuel Romero-Gómez · Hospital Universitario Virgen del Rocío de Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2023-01-31
Completion
2024-01-08

Countries

  • Germany
  • Greece
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688149 on ClinicalTrials.gov