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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.

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…

ClinicalTrials.gov IDNCT07602023

PhaseNot Applicable

Enrollment150

SponsorAngelina Passaro

Age50 Years

SexALL

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Conditions studied

Prediabetes / Type 2 Diabetes

About this study

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.

Primary outcomes

Triglyceride concentrations after oral fat loading test (From enrollment after two years at the end of the enrollment)
Progression from prediabetes to type 2 diabetes (At 36-month follow-up)

Eligibility information

Inclusion Criteria: * Males and females aged 50-70 years * BMI between 25-30 kg/m2 * HbA1c ≤7% for T2D * HbA1c ≤6.5% for prediabetes * HbA1c ≤5.7% for controls * Signed Project Information and Informed Consent Form * Signed Data Processing Consent Form Exclusion Criteria: * Lipid-lowering therapy with ezetimibe, fenofibrate, omega-3 fatty acids, or other drugs that can interfere with lipoprotein absorption and metabolism * Chronic Kidney Disease (CKD) with estimated glomerular filtration rate (eGFR) \<60 ml/min and renal impairment (e.g., uACR ≥30 mg/mmol) for 3 months or more * Secondary or syndromic forms of obesity * Patients on insulin therapy * All acute and chronic conditions that, in the opinion of the investigators, may cause bias. * Hospitalization for acute illness or major surgery in the last 6 months * Patients on stable therapy for less than 3 months * Allergy or intolerance to one or more components of the meal used in the protocol * Pregnancy or breastfeeding * Habitual consumption of alcoholic beverages (\>20 g/day for females and \>30 g/day for males) or unwillingness to abstain from alcoholic beverages during the study run-in period * All subjects who do not consent to participate in the study

Study locations

University Hospital "Sant'Anna" of Ferrara, Ferrara, Ferrara 44124 Italy
Nucleo di Cure Primarie di Poggio Renatico - Medicina di Gruppo Poggio Rete Salute Via Salvo D'Acquisto, 1/a, Poggio Renatico, Ferrara 44023 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.