Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- brain insulin sensitivity
研究概览
简要总结
Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HbA1c <6.5%
- •Age between 40 and 75 years
- •No intake of antidiabetic drugs or drugs for weight reduction
- •no steroid intake
- •Stable medication over 10 weeks before the start of the study
排除标准
- •Persons who wear non-removable metal parts in or on the body.
- •Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
- •Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
- •Persons with hearing impairment or increased sensitivity to loud noises
- •People with claustrophobia
- •Minors or non-consenting subjects are also excluded
- •Subjects with an operation less than 3 months
- •Simultaneous participation in other studies
- •Neurological and psychiatric disorders
- •Subjects with hemoglobin Hb <11 g / dl
- •Hypersensitivity to any of the substances used
结局指标
主要结局
brain insulin sensitivity
时间窗: 30 minutes after administration of nasal insulin
fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity.
次要结局
- Glucose tolerance(2 hours)
- Cognitive function(1 hours)
- Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight.(8 weeks)
- whole-body insulin sensitivity(2 hours)
- Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition .(8 weeks)
- Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance .(8 weeks)