RecruitingNCT07602023

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

Enrollment

150 participants

Start Date

May 14, 2024

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 50 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Oral Fat Load Test for people with prediabetes / type 2 diabetes. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOral 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

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NCT07602023


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