Influence Of Extra Virgin Olive Oil and Butter on Endothelial Function in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change of Endothelial function from pre meal to post meal period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.
结局指标
主要结局
Change of Endothelial function from pre meal to post meal period
时间窗: before meal, 1 hour, 3 hour, 5 hour after meal
Flow mediated dilation technique by ultrasound
次要结局
- Serum glucose(before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal)
- Gastric emptying rate(before meal, 15, 90, 120, 180, 240, 300 minutes after meal)
研究者
Concetta Irace
Clinical Professor
University Magna Graecia