Dietary Fat and Endothelial Function in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence Of Extra Virgin Olive Oil and Butter on Endothelial Function in Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Dietary Supplement: EVOO supplementation
* Dietary Supplement: Butter supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over, interventional, controlled study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVOO-Butter<br>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. | Dietary Supplement: EVOO supplementation<br>* We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO<br>Dietary Supplement: Butter supplementation<br>* We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter<br>|
| Experimental: Butter-EVOO<br>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 | Dietary Supplement: EVOO supplementation<br>* We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO<br>Dietary Supplement: Butter supplementation<br>* We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | before meal, 15, 90, 120, 180, 240, 300 minutes after meal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMD, post prandial glycemia, EVOO, butter, Endothelial function, gastric emptying, dietary fat