EUCTR2018-000684-82-NL进行中(未招募)1 期
The effect of lactate administration on cerebral blood flow during hypoglycemia
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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