Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp
研究概览
简要总结
Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.
The investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HbA1c ≤6.0%
- •normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
排除标准
- •Not removable metal parts in or on the body
- •manifest cardiovascular disease
- •claustrophobia
- •recent surgery (less than 3 months)
- •Simultaneous participation in other studies
- •Acute disease or infection within the last 4 weeks
- •neurological and psychiatric disorders
- •treatment with centrally acting drugs
- •hemoglobin Hb <13g / dl
- •Hypersensitivity to any of the substances used
研究组 & 干预措施
Insulin nasal spray
160 Units of human insulin as nasal spray
干预措施: intranasal insulin (Drug)
Placebo nasal spray
Nasal spray containing placebo solution
干预措施: Placebo (Drug)
结局指标
主要结局
Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp
时间窗: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp
次要结局
- Correlation with autonomous nervous system activity(10 - 150 minutes post nasal spray)
- Peripheral insulin sensitivity(10-90 min and 70-90 min during hyperglycemic clamp)
- Correlation with brain insulin sensitivity(15-30 minutes post insulin nasal spray)
- Differential effects in lean and overweight(0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp)