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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 2
Study Overview
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).
Detailed Description
Diabetes is a serious chronic disease characterized by elevated blood glucose levels resulting from abnormal pancreatic β-cell biology in relation to insulin action.
According to estimates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), diabetes is the eighth leading cause of death and disability worldwide, affecting nearly 460 million people of all ages and in all countries in 2019. It is currently estimated that approximately 529 million people of all ages worldwide are living with diabetes, with a global age-standardized prevalence of 6.1%.
Estimates from the International Diabetes Federation (IDF) indicate that global health expenditure on diabetes reached 910 billion euros in 2021 and is projected to exceed 1,000 billion euros by 2045.
Diabetes is also a major risk factor for ischemic heart disease and stroke, which according to GBD estimates are the first and second leading causes of disease globally. Diabetes itself is associated with increased mortality compared with non-diabetic individuals, worsens prognosis for all other diseases, increases premature mortality (Years of Life Lost, YLL), years lived with disability (Years Lived with Disability, YLD), and loss of healthy life years (Disability-Adjusted Life Years, DALY). Globally, diabetes accounted for 37.8 million YLL due to premature death and 41.4 million YLD, for a total of 79.2 million DALYs in 2021. Type 2 diabetes accounted for the vast majority of YLL, YLD, and DALYs attributable to diabetes. The global age-standardized DALY rate for diabetes was 915 per 100,000, with YLL and YLD rates of 437 and 478 per 100,000, respectively. In Italy, age-standardized DALYs in 2021 were 521.1 thousand, representing an 11.5% reduction compared with 2010, whereas increases were observed in the rest of Western Europe, in high-income countries, and globally.
Type 1 diabetes (T1D) and type 2 diabetes (T2D) are the most common forms of the disease and are diagnosed according to well-defined criteria reported in the operational manual. T1D often develops during childhood, whereas T2D has a strong genetic component and is strongly associated with obesity and a sedentary lifestyle. Cases of T2D account for approximately 96% of all diabetes cases.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Angelina Passaro
Professor
University Hospital of Ferrara