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临床试验/NCT01676103
NCT01676103已完成1 期

The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD

研究概览

简要总结

The objective of this experiment is:

  • Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD.
  • Secondary: To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise stress.

Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it can drastically reduce quality of life. It has been hypothesized that tyrosine may impact upon individuals suffering from PD. There is ample evidence in animal models that supports our theory; however there is no clinical evidence of the impact tyrosine supplementation may have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses. Positive findings that supplemental tyrosine increases BP and HR in people with PD during daily activities such as standing up from a chair and walking can lead to new therapies to improve Parkinsonian orthostatic hypotension.

Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve after tyrosine supplementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PD according to the UK Brain Bank Diagnostic criteria
  • Diagnosis of orthostatic hypotension according to EFNS guidelines
  • Able to walk on a treadmill comfortably for 6-10 minutes
  • Currently taking levodopa
  • Subjects between the age of 50-80 years old

排除标准

  • Currently taking an amino acid supplement
  • Currently taking medication that affects BP
  • Normal BP response to testing

结局指标

主要结局

Determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD

时间窗: 7 days

Orthostatic Blood Pressure Testing: Subjects will sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes. Subjects will then stand upright for 3 minutes. Blood pressure will be taken every minute for those 3 minutes. A drop in systolic BP of 20 mmHg and a 10 mmHg in diastolic drop within these 3 minutes indicates orthostatic hypotension according to the American Academy of Neurology. Blood Samples: Norepinephrine and tyrosine will all be examined via blood samples drawn by a medical assistant or physician from the forearm vein in vacutainer tubes. Two vacutainers of three cc's of blood will be collected and frozen until analyzed.

次要结局

  • To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on heart rate, blood pressure, and norepinephrine responses during acute exercise stress.(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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