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.

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).

NCT Number	NCT07602023
Lead Sponsor	Angelina Passaro Collaborators: University Hospital of Ferrara, S. Anna Hospital, Azienda USL Ferrara, Università degli Studi di Ferrara
Conditions	Prediabetes / Type 2 Diabetes
Enrollment	150 participants
Start Date	2024-05-14
Primary Completion	2026-05-14 (estimated)
Study Completion	2028-05-14 (estimated)
Updated on ClinicalTrials.gov	2026-05-22