A Trial of Daily Ultraviolet Therapy to Reduce Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- 24 hour ambulatory blood pressure measurement
研究概览
简要总结
The investigators have shown that a single dose of ultraviolet irradiation (as found in sunlight) will lower blood pressure for around one hour. They are now testing whether daily UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure.
They will also measure the effect of daily UVA on other cardiovascular risk factors.
详细描述
Epidemiological studies suggest that sunlight reduces all cause mortality, and particularly cardiovascular mortality.
The investigators have previously shown vasodilatation and a transient fall in blood pressure following irradiation of human volunteers with 2 standard erythemal doses of UVA radiation. This was independent of vitamin D and temperature rise and correlated with a nitric oxide synthase independent mobilisation of NO stores from the skin to the systemic circulation.
In this randomised, sham-controlled, cross-over double blind study, they will measure whether twice daily UVA administration can produce a sustained fall in BP and other cardiovascular risk factors in a cohort of pre-hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-hypertensives (BP 120-139/80-89).
- •Fitzpatrick skin types 2 and above (i.e. the ability to tan)
排除标准
- •History of skin cancer.
- •Fitzpatrick type 1 skin (always burns, never tans).
- •Red hair.
- •Family history of melanoma in first degree relative.
- •Atypical naevus syndrome.
- •Planned holiday or foreign travel during and for 4 weeks before the period of the study.
- •Concurrent administration of:
- •anti-hypertensive medication,
- •photosensitising medication,
- •systemic immunosuppressive medication.
结局指标
主要结局
24 hour ambulatory blood pressure measurement
时间窗: Two weeks
Before and after active and sham intervention period. Subjects will wear a 24 hour ambulatory blood pressure monitor for the 24 hour period before and after each 2 week intervention period. Change in 24 hour ambulatory blood pressure measurement will be the outcome measure.
次要结局
- Blood pressure(Two weeks)
- Body Mass Index(Two weeks)
- Mood(Two weeks)
- Heart rate(Two weeks)
- Fasting insulin level(Two weeks)
- Lipid profile(Two weeks)
- Adipokine profile(Two weeks)
- Adaptive pigmentation(Two weeks)
- Waist-Hip Ratio(Two weeks)
- Glucose tolerance test(Two weeks)
- HbA1c (glycosylated haemoglobin)(Two weeks)
- Bio-impedance for body fat(Two weeks)
- Serum Vitamin D level(Two weeks)
- Physical activity level- composite measure.(Two weeks)