EUCTR2014-001777-13-NL进行中（未招募）不适用
The effect of insulin-induced hypoglycemia on brain lactate accumulation and regional cerebral blood flow in patients with type 1 diabetes mellitus with and without hypoglycemia unawareness and non-diabetic controls
Radboud umc0 个研究点开始时间: 2014年6月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Inclusion criteria for healthy subjects
- •-Age: 18-50 years
- •-Body-Mass Index: 18-30 kg/m2
- •-Blood pressure: <160/90 mmHg
- •Inclusion criteria T1DM patients with normal hypoglycemic awareness
- •-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
- •Inclusion criteria T1DM patients with hypoglycemia unawareness
- •-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: >3
- •-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 21
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for healthy subjects
- •-Inability to provide informed consent
- •-Presence of any medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
- •-Use of any medication, except for oral contraceptives
- •-MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
- •Exclusion criteria for all T1DM patients
- •-Inability to provide informed consent
- •-Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, anxiety disorders, or complications of T1DM (including neuropathy and retinopathy)
- •-Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy
- •-MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
研究者
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