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Triglyceride-rich LIPoproteins and INflammatory Cytokines After Oral FAT Loading as Potential Early Biomarkers of the Risk of Progression Towards DIABETES and Development of Complications. LIPINFAT Diabetes Study.

NCT07602023 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-05-22

No results posted yet for this study

Summary

The aim of the study is to evaluate whether the Oral Fat Loading Test (OFLT) determines a different response in terms of the quantity, quality, and kinetics of triglyceride-rich lipoproteins in subjects with T2D, prediabetics, and control subjects, and whether triglyceride-rich lipoproteins and inflammatory cytokines after OFLT are potential early biomarkers of the risk of progression to diabetes and the development of complications in a general practice setting.

To address these questions, a hybrid cohort study was designed by identifying three groups of subjects: T2D and prediabetics (exposed and near-exposed) and control subjects (unexposed).

Conditions

  • Prediabetes / Type 2 Diabetes

Interventions

DIAGNOSTIC_TEST

Oral Fat Load Test

After a 12-hour overnight fast, each participant will be given a sugar-free mascarpone cream containing 75 g of fat. Blood samples will be collected before (OFL Time -1 minute) and 1 (OFL Time +1 hour), 2 (OFL Time +2 hours), 3 (OFL Time +3 hours), 4 (OFL Time +4 hours), and 6 (OFL Time +6 hours) hours after the OFL.

Sponsors & Collaborators

  • University Hospital of Ferrara

    collaborator OTHER

  • S. Anna Hospital

    collaborator OTHER

  • Azienda USL Ferrara

    collaborator OTHER_GOV

  • Università degli Studi di Ferrara

    collaborator OTHER

  • Angelina Passaro

    lead OTHER

Principal Investigators

  • Angelina Passaro, Degree in Medicine and Surgery · University Hospital of Ferrara "Sant'Anna"

  • Luca Catapano, Degree in Medicine and Surgery · Azienda USL Ferrara

  • Angelina Passaro, Degree in Medicine and Surgery · University Hospital of Ferrara "Sant'Anna"

  • Angelina Passaro, Degree in Medicine and Surgery · University Hospital of Ferrara "Sant'Anna"

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2026-05-14
Completion
2028-05-14

Countries

  • Italy

Study Locations

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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 NCT07602023 on ClinicalTrials.gov