NCT00626080已完成不适用
Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes
Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET
研究概览
简要总结
The aim of this study is to test the hypothesis that subcutaneous administration of insulin detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose metabolism and/or cerebral blood flow in brain regions associated with appetite regulation, to account for the reported difference in weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetic patients;
- •Diabetes duration =/> 1 year;
- •HbA1c ~ 7,5%;
排除标准
- •Recent onset of DM;
- •BMI < 18 OR > 35 kg/m2;
- •History of major heart/renal disease;
- •Severe untreated proliferative retinopathy;
- •History of recurrent severe hypoglycaemia;
- •(History of) brain disorders;
- •Alcohol abuse,(History of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants;
- •Current psychiatric disease/treatment;
- •(history of) eating disorders;
- •History of severe head trauma accompanied by loss of consciousness;
- •Any endocrine disease not well controlled for at least 3 months;
- •Inability to undergo MRI;
- •Visual acuity < 0.3;
- •Known or suspected allergy to trial product or related products
结局指标
主要结局
Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET
时间窗: After 12 weeks of treatment
Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET
时间窗: After 12 weeks of treatment
次要结局
- CSF insulin concentration(After 12 weeks of treatment)
- Activity in brain regions associated with appetite control, as determined by fMRI(After 12 weeks of treatment)
- Weight change(After 12 weeks of treatment)
研究者
研究点 (2)
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