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临床试验/NCT04021732
NCT04021732已完成不适用

Effects of Exercise on Metabolic Parameters in Treated Patients With Classical Homocystinuria: a Research Project on a Small Sample Size, Compared to Healthy Controls.

University of Lausanne2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Plasma homocysteine concentration

研究概览

简要总结

The aim of this research project is to compare the effect of an aerobic exercise session in two different populations. Sampling biological material and collecting health-related personal data entails minimal risks and burdens. Participants will be asked to perform 30 minutes of an aerobic exercise on an ergocycle at a fixed power output to correspond to a moderate intensity for a sedentary population.

详细描述

Background Among genetic causes of hyperhomocysteinemia, classical homocystinuria, manifest not only with vascular diseases but also with neurological symptoms. This is related to the higher homocysteine concentration of up to 150-300 μmol/l without treatment. Recently, some articles have shown that mild and temporary hyperhomocysteinemia may follow exercise in a healthy population. Investigators hypothesized that increase in homocysteine may be of greater importance in patients with classical homocystinuria where cystathionine beta-synthase deficiency prevents homocysteine metabolism.

Objective To investigate the effect of an aerobic exercise in patients with classical homocystinuria on metabolic parameters compared to healthy controls.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Any clinically instable concomitant disease
  • Individuals with acute cardiac events, syncope, rhythm disturbances or unstable hypertension in the past 6 months
  • Individuals with vitamins B9 or B12 deficiencies
  • Homocysteine > 100 µmol/l (for subjects)
  • Homocysteine > 20 µmol/l (for controls)

结局指标

主要结局

Plasma homocysteine concentration

时间窗: -90 minutes before exercise to 24 hours after a 30 minute exercise

Change in homocysteine concentration after a 30 minute exercise at fixed wattage

次要结局

  • Dietary parameters(During 3 days before and on the day of the exercise (day 1))
  • Indirect calorimetry(-90 minutes before exercise to the end of exercise (+30 minutes))
  • Plasma amino acid profile(-90 minutes before exercise to 24hours after a 30 minute exercise)
  • Plasma Insulin concentration(-90 minutes before exercise to 24 hours after a 30 minute exercise)
  • Plasma lactate concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
  • Plasma glucagon concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
  • Plasma free fatty acids concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
  • Plasma ketone bodies concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
  • Plasma cortisol concentration(-90 minute before exercise to 24 hours after a 30 minute exercise)
  • Blood pressure(-90 min before exercise to 24 hours after a 30 minute exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christel Tran

Associate physician

University of Lausanne

研究点 (2)

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