NCT01414556已完成早期 1 期
Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- glucagon/insulin(c-peptide) absolute, incremental and area under curve values
研究概览
简要总结
Investigation of GIP effects at fasting and hypoglycemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Caucasians 18 years or older with Type 2 diabetes (WHO criteria)
排除标准
- •HbA1c >9 %
- •Liver disease (ALAT/ASAT >2 x upper normal limit)
- •Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
- •Proliferative diabetic retinopathy (anamnestic)
- •Severe arteriosclerosis or heart failure (NYHA group III og IV)
- •treatment with medication not applicable to pause for 12 hours
- •Fasting plasma glucose >15 mM on screening day.
结局指标
主要结局
glucagon/insulin(c-peptide) absolute, incremental and area under curve values
时间窗: approx. 15 minutes intervals, time 0 to 120 min
次要结局
- plasma gut hormones and nutrients(approx. 15 minutes intervals, time 0 to 120 min)
研究者
Mikkel Christensen
MD
University Hospital, Gentofte, Copenhagen
研究点 (2)
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