CompletedNot Applicable

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

Germany, Greece, Spain536 participantsStarted 2021-01-31

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Significant alcohol intake (\>30 g daily for men and \>20g daily for women).
✕. Evidence of concomitant liver disease (i.e., viral or autoimmune hepatitis, HIV, drug-induced fatty liver, hemochromatosis, or Wilson's disease).

What they're measuring

Accuracy on referral rate

Timeframe: Up to 6 months

Trial details

NCT IDNCT06688149

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-31

View on ClinicalTrials.gov More Non-alcoholic Fatty Liver Disease (NAFLD) trials