About this trial
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 criteria
Qualifiers
Males and females aged 50-70 years
BMI between 25-30 kg/m2
HbA1c ≤7% for T2D
HbA1c ≤6.5% for prediabetes
Disqualifiers
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
Trial design
Treatments tested in this trial
- Oral Fat Load Test
Treatment groups
Sponsors and collaborators
Angelina Passaro
Lead sponsor
University Hospital of Ferrara
Sponsor institution
University Hospital of Ferrara
Collaborator
S. Anna Hospital
Collaborator
Azienda USL Ferrara
Collaborator
Università degli Studi di Ferrara
Collaborator