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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-70
SponsorAngelina Passaro

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

150 Participants
are divided into 3 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