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.
Recruiting · Not specified · Angelina Passaro · registry updated 2026-05-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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).
Inclusion
- 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
Exclusion
- 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