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.

NCT07602023 | Recruiting DMC

• 1 other identifier: CE-AVEC 768-2023-Sper-AOUFe
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Prediabetes / Type 2 Diabetes

Keywords

Prediabetes, Type 2 diabetes; Oral Fat Load test; Tryglicerides; Cytokines; lipoproteins; VLDL

Outcome Measures

Primary Outcomes (2)

• Triglyceride concentrations after oral fat loading test

  Serum triglyceride concentrations measured before and 6 hours after oral fat loading test in participants with type 2 diabetes, prediabetes, and controls.

  From enrollment after two years at the end of the enrollment

• Progression from prediabetes to type 2 diabetes

  Development of type 2 diabetes according to American Diabetes Association (ADA) diagnostic criteria during follow-up in participants with prediabetes.

  At 36-month follow-up

Secondary Outcomes (7)

• Triglyceride-rich lipoprotein concentrations after oral fat loading test

  From enrollment after two years at the end of the enrollment

• Chylomicron remnant concentrations after oral fat loading test

  From enrollment after two years at the end of the enrollment

• Interleukin-1β concentration after oral fat loading test

  From enrollment after two years at the end of the enrollment

• Interleukin-18 (IL-18) concentration after oral fat loading test

  From enrollment after two years at the end of the enrollment

• Tumor necrosis factor-α (TNF-α) concentration after oral fat loading test

  From enrollment after two years at the end of the enrollment

Other Outcomes (10)

• Circulating ceramide content

  From enrollment after two years at the end of the enrollment

• Change in circulating ceramide concentrations after oral fat loading test

  From enrollment after two years at the end of the enrollment

• Proteomic analyses

  From enrollment after two years at the end of the enrollment

Study Arms (3)

Controls

Diagnostic Test: Oral Fat Load Test

Prediabetics

Diagnostic Test: Oral Fat Load Test

Diabetics

Diagnostic Test: Oral Fat Load Test

Interventions

Oral Fat Load Test DIAGNOSTIC_TEST

After a 12-hour overnight fast, each participant will be given a sugar-free mascarpone cream containing 75 g of fat. Blood samples will be collected before (OFL Time -1 minute) and 1 (OFL Time +1 hour), 2 (OFL Time +2 hours), 3 (OFL Time +3 hours), 4 (OFL Time +4 hours), and 6 (OFL Time +6 hours) hours after the OFL.

Controls; Diabetics; Prediabetics

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All individuals attending the Poggio Renatico Primary Care Unit - Poggio Rete Salute Group Medicine, Ferrara Local Health Authority who have undergone at least two diagnostic tests for diabetes in the last 12 months will be contacted.

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

Sponsors & Collaborators

• Angelina Passaro: lead
• University Hospital of Ferrara: collaborator
• S. Anna Hospital: collaborator
• Azienda USL Ferrara: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (2)

University Hospital "Sant'Anna" of Ferrara

Ferrara, Ferrara, 44124, Italy

RECRUITING

Nucleo di Cure Primarie di Poggio Renatico - Medicina di Gruppo Poggio Rete Salute Via Salvo D'Acquisto, 1/a

Poggio Renatico, Ferrara, 44023, Italy

RECRUITING

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Related Links

• Website with useful information about the study that can be shared with the patients

Biospecimen

Retention: SAMPLES WITH DNA

"Blood samples will be collected before and at 1, 2, 3, 4, and 6 hours after Oral fat Load Test. Also blood samples, performed in patients fasting for at least 12 hours will be repeated after 6, 12, 24 and 36 months from the baseline visit at follow-up visit. Vacutainer that will be collected: Vacutainer Tube - EDTA for plasma Vacutainer Serum Tubes - Red tube with added silica particles to trigger clotting, without anticoagulants for serum The serum/plasma obtained after centrifugation at 3000 rpm for 15 minutes will be stored in cryovials and preserved at -80°C 30-50 ml of midstream morning urine will also be collected

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Angelina Passaro, Degree in Medicine and Surgery

  University Hospital of Ferrara "Sant'Anna"

  STUDY CHAIR

• Luca Catapano, Degree in Medicine and Surgery

  Azienda USL Ferrara

  PRINCIPAL INVESTIGATOR

• Angelina Passaro, Degree in Medicine and Surgery

  University Hospital of Ferrara "Sant'Anna"

  PRINCIPAL INVESTIGATOR

• Angelina Passaro, Degree in Medicine and Surgery

  University Hospital of Ferrara "Sant'Anna"

  STUDY DIRECTOR

Central Study Contacts

Fabiola Castaldo, Pharmacy

CONTACT

+39 3348330516; fabiola.castaldo@unife.it

Juana M Sanz Molina, Chemistry

CONTACT

szj@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: May 22, 2026
• Study Start: May 14, 2024
• Primary Completion: May 14, 2026
• Study Completion (Estimated): May 14, 2028
• Last Updated: May 22, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)