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临床试验/NCT01805700
NCT01805700已完成不适用

Effects of Acute Intake of Caffeine Enhanced Energy Drinks on Blood Glucose, Some Physiological Parameters and Cognitive Performance in Patients With Type 1 Diabetes

The Royal Bournemouth Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Changes in blood glucose level in all patients as a measure of tolerability

研究概览

简要总结

The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive performance in patients with type 1 diabetes.

Knowledge acquired may inform a wider study of the impact of these drinks.

This is a randomised, cross over blinded study in which all participants will participate in the 3 arms of the study.

The study will consist of 3 phases, each lasting 3 days. A different study drink will be administered during each phase. There will be an initial screening visit and a pre- study visit before each study phase. Each participant will make 10 visits to the research centre.

There will be a week wash out period between each study phase. Prior to each study phase, there will be a 3 day caffeine and alcohol abstinence run-in period.

Study drinks will be matched for taste and volume (as far as possible) and will be administered by the use of opaque cups, lids and straws to enable double-blind randomisation for both researcher and participants. Administration of the study drink to participants will be based on Latin squares to provide a balanced treatment order.

During the 3 days study period; participants will be required to abstain from all other caffeine containing beverages or confectioneries.

The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced energy drinks is developed following acute short term ingestion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Male and female adults aged ≥18 years
  • Confirmed diagnosis of Type 1 diabetes of more than one year duration
  • Participants who use multiple daily injections of basal and meal-time analogue insulin.
  • Ability to perform daily finger stick measurements of blood glucose levels
  • Adequate contraceptive control
  • Provision of informed consent

排除标准

  • Hypoglycaemia unawareness
  • Coronary heart disease
  • Cardiac arrhythmia
  • Structural heart lesions,
  • Autonomic neuropathy
  • Psychiatry illness,
  • Caffeine intolerance
  • Unable to provide informed consent

结局指标

主要结局

Changes in blood glucose level in all patients as a measure of tolerability

时间窗: Day 1, Day 2 and Day 3

次要结局

  • The effects on certain mood states, e.g. energetic arousal, tense arousal and hedonic tone following the consumption of caffeinated energy drinks in comparison with caffeine free glucose in patients with type 1 diabetes(Day 1, day 2 and day 3)
  • Changes in reaction time and digit symbol substitution test score(Day 1, day 2 and day 3)
  • Changes in heart rate, systolic and diastolic blood pressure in all patients.(Day 1, day 2 and day 3)

研究者

发起方
The Royal Bournemouth Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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