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.

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Triglyceride concentrations after oral fat loading test — From enrollment after two years at the end of the enrollment
  Serum triglyceride concentrations measured before and 6 hours after oral fat loading test in participants with type 2 diabetes, prediabetes, and controls.
• Progression from prediabetes to type 2 diabetes — At 36-month follow-up
  Development of type 2 diabetes according to American Diabetes Association (ADA) diagnostic criteria during follow-up in participants with prediabetes.

Trial sites (2)