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This study evaluates whether triglyceride-rich lipoproteins and inflammatory cytokines measured after an oral fat load test can serve as early biomarkers of the risk of progressing to type 2 diabetes and developing complications. It uses an oral fat load test and can include people aged 50-70 with a body mass index of 25-30 who have type 2 diabetes, prediabetes, or are healthy controls. It is a study without an assigned phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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