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DIABETOLOGY AND ITS COMPLICATIONS

L-FABP-NC

Urinary Liver-Fatty Acid Binding Protein (L-FABP): assessment of a urinary biomarker predictive of the development of chronic kidney disease (CKD) in at-risk populations

A prospective study on the role of the urinary protein L-FABP as an early biomarker of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus.
The project integrates clinical data and machine-learning algorithms to stratify renal and cardiovascular risk.

OngoingStatus
since 2022Duration
Jan 2022Start
Diabetology and its complicationsArea

The project

L-FABP-NC is a multi-year research project, conducted from 2022 to 2025, promoted by the Rome American Hospital in collaboration with Nefrocenter and the University of Campania "Luigi Vanvitelli".
The project was conceived to address the need to identify early on the risk of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus, before renal damage becomes clinically evident and irreversible.
The research assesses the role of the urinary protein Liver-Fatty Acid Binding Protein as a sensitive, non-invasive biomarker, capable of detecting subclinical renal alterations and contributing to cardiovascular risk stratification.
The observational study includes a new enrolment phase for each study year, to allow the structured collection of clinical, biochemical, instrumental and urinary data and the assessment of the progression of renal damage throughout the project, as well as its relationships with cardiovascular risk.

Results

The main objective of the project is to develop a multifactorial predictive model, supported by predictive algorithms, capable of promptly identifying diabetic subjects at risk of chronic kidney disease (CKD) and cardiovascular complications, starting from a non-invasive predictive test.
The project also aims to guide more personalised therapeutic decisions, fostering early and targeted management of at-risk patients.
Through the urinary measurement of L-FABP and its integration with clinical, anamnestic, biochemical and instrumental parameters, the study intends to improve the ability to predict the progression of renal disease and to reduce the incidence of associated cardiovascular events.
The project involves the construction of a clinical and instrumental database dedicated to patients with type 2 diabetes mellitus and preserved renal function, with the aim of assessing the predictive value of the urinary biomarker L-FABP in the development of chronic kidney disease (CKD).
The expected result is the creation of a predictive algorithm capable of integrating clinical, biochemical, cardiovascular and urinary data to identify higher-risk patients at an early stage.

Related publications

Scientific evidence

2025
Diabetology and its complications Review

A Neglected Complication of Insulin Therapy Due to Errors in Injection Technique: Skin Lipohypertrophies: A Narrative Review

Guarino G, Satta E, Gentile S

2025
Diabetology and its complications Review

Advance Insulin Injection Technique and Education With FITTER Forward Expert Recommendations

Kerr D, Klonoff DC, et al.

2024
Diabetology and its complications Case series / Case report

Insulin-Related Skin Lipohypertrophy in Type Two Diabetes: A Clinical Study of a Case Series, with Ultrasonographic and Histopathologic Implications

Gentile S, Guarino G, Ronchi A, Satta E, Della-Corte T, Fulgione E, Babino G, Mattera E, Martedì E, Di Martino R, Fiorentino…

Diabetology
2022
Diabetology and its complications Observational study

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Gentile S, Guarino G, Della Corte T, Satta E, Pipicelli AMV, Romano C, Alfarone C, Lamberti R, Di Maio A

Italian publication
2022
Diabetology and its complications Original

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Guarino G, Della-Corte T, Satta E, Romano C, Alfarone C, Corigliano G, Corigliano M, Cozzolino G, Brancario C, Martino C, Oliva D,…

Likely Italian medical journal
2021
Diabetology and its complications Poster

Technological innovation of Continuous Glucose Monitoring (CGM) as a tool for commercial aviation pilots with insulin-treated diabetes and stakeholders/regulators: A new chance to improve the directives?

Furia A, et al.

Italian/Aeromedical conference