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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVOO-Butter | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVOO supplementation | Dietary Supplement | We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Endothelial function from pre meal to post meal period | Flow mediated dilation technique by ultrasound | before meal, 1 hour, 3 hour, 5 hour after meal |
| Measure | Description | Time Frame |
|---|---|---|
| Serum glucose | glucose-hexokinase method | before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal |
| Gastric emptying rate | Ultrasound antrum measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Magna Graecia | Catanzaro | 88100 | Italy |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Cross-over, interventional, controlled study.
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| Butter supplementation | Dietary Supplement | We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter |
|
| before meal, 15, 90, 120, 180, 240, 300 minutes after meal |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |