Dietary Fat and Endothelial Function in Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Dietary Supplement: EVOO supplementationDietary Supplement: Butter supplementation
- Registration Number
- NCT04812782
- Lead Sponsor
- University Magna Graecia
- Brief Summary
The purpose of this study is to evaluate the effects of the add-on of extra vergin olive oil or butter to a high glycemic index meal on endothelial function in subjects with type 1 Diabetes and healthy subjects.
- Detailed Description
Impaired endothelial function is an early manifestation of atherosclerosis and predictor of incident cardiovascular events. Diabetes affects arterial vasodilation by reducing the bioavailability of NO and more in general affecting the balance between the atheroprotective and atherothrombotic properties of the endothelium. A consistent number of studies has so far documented that Mediterranean-style diet associates with reduced risk of cardiovascular diseases and diabetes. Intake of extra virgin olive oil (EVOO), that is a common but not necessary ingredient of the Mediterranean diet, seems to further enhance the beneficial cardiovascular effect and reduce the incidence of diabetes. We have designed the present study to test whether EVOO supplementation acutely influences endothelial function in T1DM. EVOO supplementation wil be compared to butter supplementation in the context of a high glycemic index (GI) meal that is known to increase PP glycemic burden.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- age ≥ 18 years,
- diagnosis of type 1 diabetes since at least 1 year,
- HbA1c <8.5% (69 mmol/mol),
- stable insulin therapy for at least 3 months before the enrolment into the study
- pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description EVOO-Butter EVOO supplementation All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with EVOO and the second with butter. Butter-EVOO EVOO supplementation All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with Butter and the second with EVOO EVOO-Butter Butter supplementation All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with EVOO and the second with butter. Butter-EVOO Butter supplementation All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with Butter and the second with EVOO
- Primary Outcome Measures
Name Time Method Change of Endothelial function from pre meal to post meal period before meal, 1 hour, 3 hour, 5 hour after meal Flow mediated dilation technique by ultrasound
- Secondary Outcome Measures
Name Time Method Serum glucose before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal glucose-hexokinase method
Gastric emptying rate before meal, 15, 90, 120, 180, 240, 300 minutes after meal Ultrasound antrum measurement
Trial Locations
- Locations (1)
University Magna Graecia
🇮🇹Catanzaro, Italy