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RECRUITING
NCT07602023

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.

Sponsor: Angelina Passaro

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

50 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-05-14

Completion Date

2028-05-14

Last Updated

2026-05-22

Healthy Volunteers

No

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.

Locations (2)

University Hospital "Sant'Anna" of Ferrara

Ferrara, Ferrara, Italy

Nucleo di Cure Primarie di Poggio Renatico - Medicina di Gruppo Poggio Rete Salute Via Salvo D'Acquisto, 1/a

Poggio Renatico, Ferrara, Italy