Triglyceride-rich lipoproteins and inflammatory markers after an oral fat load in people with prediabetes or type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses an Oral Fat Load Test to compare the triglyceride-rich lipoprotein response and cytokine levels among adults aged 50–70 with type 2 diabetes, prediabetes, and controls. The goal is to see if post-load lipoprotein activity and inflammatory markers can serve as early biomarkers for progression to diabetes and related complications in a real-world primary care setting. The study design includes three cohorts (diabetes, prediabetes, controls), with measured kinetics of lipoproteins and cytokines after the fat challenge. Exclusion criteria minimize confounding lipoprotein metabolism, such as lipid-lowering therapy, kidney disease, recent major health events, and pregnancy. Findings could inform risk stratification and early interventions if post-load markers correlate with progression risk.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Luca Catapano, Degree in Medicine and Surgery — Azienda USL Ferrara
• Study coordinator: Fabiola Castaldo, Pharmacy
• Email: fabiola.castaldo@unife.it
• Phone: +39 3348330516

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.