Triglyceride-rich LIPoproteins and INflammatory Cytokines After Oral FAT Loading as Potential Ear… (NCT07602023) | Clinical Trial Compass
RecruitingNot Applicable
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.
Italy150 participantsStarted 2024-05-14
Plain-language 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).
Who can participate
Age range
50 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Triglyceride concentrations after oral fat loading test
Timeframe: From enrollment after two years at the end of the enrollment