NCT07602023Recruiting
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.
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 2 Jan 2026
- Start date
- 14 May 2024
- Primary completion date
- 14 May 2026
- Lead sponsor
- Angelina Passaro
- Diseases
- Type 2 diabetes
- NCT number
- NCT07602023
What you commit to
- Study type: Observational
- Planned participants: 150
- From 14 May 2024 to the primary completion date, 14 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lipid-lowering therapy with ezetimibe, fenofibrate, omega-3 fatty acids, or other drugs that can interfere with lipoprotein absorption and metabolism
- Patients on insulin therapy
- Patients on stable therapy for less than 3 months
Other illness
- 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
- Allergy or intolerance to one or more components of the meal used in the protocol
Lab values
- 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
Other
- Secondary or syndromic forms of obesity
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital "Sant'Anna" of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Nucleo di Cure Primarie di Poggio Renatico - Medicina di Gruppo Poggio Rete Salute Via Salvo D'Acquisto, 1/a Coordinator of this site? Confirm its status | Poggio Renatico | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.