Proof-of-concept Study to Investigate Hand and Foot Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes Participant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Macrovascular endothelial function
研究概览
简要总结
The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Specific diets with high polyphenol content are associated with lower incidence of cardiovascular disease and can improve macrovascular function when consumed acutely and chronically. Which role the smallest blood vessels (microcirculation) play in this and if the microcirculation responds to therapies is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation.
The current randomised controlled cross-over proof-of-concept study will test the acute effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of hands and feet together with macrovascular function of upper and lower extremities in healthy and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as compared to placebo can acutely increase microvascular vasodilation and macrovascular endothelial function in arms and legs together with arterial stiffness in both healthy and type 2 diabetes participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Placebo and cocoa flavanols will be delivered in same number of identical appearing capsules
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, 20-70 years
- •BMI 20-30 kg/m^2
排除标准
- •Diabetes mellitus
- •Symptoms of acute infection
- •Cardiac rhythm other than sinus
- •Active malignancy
- •Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
- •Active vasoactive medication.
- •Type 2 Diabetes:
- •Inclusion Criteria:
- •Type 2 diabetes mellitus
- •20-70 years
- •BMI 20-30 kg/m^2
- •Exclusion Criteria:
- •Symptoms of acute infection
- •Cardiac rhythm other than sinus
- •Active malignancy
- •Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
- •Active vasoactive medication.
结局指标
主要结局
Macrovascular endothelial function
时间窗: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Flow-mediated dilation determined with ultrasound in brachial and common femoral artery
Microvascular dilation
时间窗: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Microvascular diameter increase in response to 5 min limb occlusion on hands and feet
次要结局
- Blood pressure(Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo)
- Arterial stiffness(Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo)
- Leg perfusion pressure(Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo)