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临床试验/NCT03949075
NCT03949075已完成不适用

Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Maximal systemic oxygen uptake

研究概览

简要总结

The phenotype based on the insertion/deletion (I/D) polymorphism of the human angiotensin converting enzyme (ACE) gene has been associated with individual training response. Briefly, intervention studies have demonstrated an 11-fold greater training-induced improvement in muscular endurance for ACE I/I homozygotes compared to ACE D/D homozygotes.

Importantly, the ACE I/D polymorphism causes large inter-individual differences in serum ACE activity. Because the ACE D/D genotype is characterized by high plasma ACE activity and potentially blunted endurance exercise training response, it appears likely that ACE inhibitors (ACEi) have the potential to improve the outcome of exercise training for ACE D/D homozygotes.

Thus, in the present study the investigators apply a randomized double-blind placebo-controlled longitudinal design to investigate whether pharmacological inhibition of ACE activity can amplify the exercise training response in healthy humans carrying either the ACE D/D or ACE I/I genotype.

The study hypothesis is that inhibition of ACE activity in healthy humans with the ACE D/D genotype will amplify the health beneficial effects of exercise training while this is not the case in ACE I/I homozygotes.

研究设计

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

盲法说明

The present study is double-blinded with regard to ACE genotype and study medication and the blinding is kept until completion of the trial

入排标准

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

入选标准

  • Aged 20-50 years

排除标准

  • 未提供

研究组 & 干预措施

Enalapril treatment

Experimental

干预措施: Enalapril (Drug)

Placebo treatment

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Maximal systemic oxygen uptake

时间窗: 20 minutes

Training-induced changes in maximal systemic oxygen uptake (L/min) is evaluated with an incremental maximal cycle protocol on a cycle ergometer

Skeletal muscle endurance

时间窗: 5 minutes

Training-induced changes in muscle endurance evaluated as changes in duration (sec) of a repetitive elbow-flexion exercise

次要结局

  • Blood volume(20 minutes)
  • Steady-state systemic oxygen uptake(10 minutes)
  • Muscle strength(1 minute)
  • Left ventricular (LV) mass(45 minutes)
  • Skeletal muscle oxidative capacity(60 minutes)
  • Mitochondrial biogenesis(60 minutes)
  • Fat free mass(20 minutes)
  • Body fat percentage(20 minutes)
  • LV end-diastolic volume(45 minutes)
  • Mean arterial pressure (MAP)(10 minutes)
  • Fat mass(20 minutes)
  • Endurance performance(15 minutes)
  • LV mean wall thickness(45 minutes)
  • LV stroke volume(45 minutes)
  • LV ejection fraction(45 minutes)

研究者

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

Nikolai Nordsborg

Associate Professor

University of Copenhagen

研究点 (1)

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