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临床试验/EUCTR2018-000684-82-NL
EUCTR2018-000684-82-NL进行中(未招募)1 期

The effect of lactate administration on cerebral blood flow during hypoglycemia

Radboud university medical center0 个研究点目标入组 10 人开始时间: 2018年3月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Diabetes duration = 1 year
  • -Age: 18-50 years
  • -Body-Mass Index: 18-30 kg/m2
  • -HbA1c: 42-75 mmol/mol (6-9%)
  • -Outcome Clarke questionnaire: 0-1
  • -Blood pressure: <160/90 mmHg
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Inability to provide informed consent
  • -Use medication other than insulin, except for oral contraceptives or stable thyroxin supplementation therapy
  • -Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, or cardiac failure, known liver disease, anxiety disorders or a history of panic attacks.
  • -Microvascular complications of T1DM:
  • oProliferative retinopathy
  • oSymptomatic diabetic neuropathy (including autonomic neuropathy)
  • oNephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate <60ml/min/1.73m2
  • -MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)

研究者

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