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 now
Conditions studied: Prediabetes / Type 2 Diabetes
In brief
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).
Key facts
- Study ID
- NCT07602023
- Run by
- Angelina Passaro
- People needed
- 150
- Starts
- 2024-05-14
- Expected to finish
- 2028-05-14
- Last updated by the study team
- 2026-05-22
Who can join
Age: 50 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University Hospital "Sant'Anna" of Ferrara — Ferrara, Ferrara, Italy (enrolling)
- Nucleo di Cure Primarie di Poggio Renatico - Medicina di Gruppo Poggio Rete Salute Via Salvo D'Acquisto, 1/a — Poggio Renatico, Ferrara, Italy (enrolling)
Full record on ClinicalTrials.gov
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