Type 1 Diabetes
Conditions
Keywords
Endothelial function, FMD, gastric emptying, post prandial glycemia, dietary fat, EVOO, butter
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.
Interventions
DIETARY_SUPPLEMENTEVOO supplementation
We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO
DIETARY_SUPPLEMENTButter supplementation
We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cross-over, interventional, controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed