Insulinsensitivität Des Menschlichen Zentralnervensystems Mit Fortschreitendem Alter: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Brain insulin sensitivity in different age,weight and sex groups
研究概览
简要总结
Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. As the population gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been suggested as a likely shared common pathophysiological mechanism. However, the neural processes that determine how insulin resistance is are connected to the onset and progression of T2D and dementia remain unclear. In this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive processes will be assessed as secondary variables.
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
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body-Mass Index (BMI) between 19-35 kg/m2
- •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
结局指标
主要结局
Brain insulin sensitivity in different age,weight and sex groups
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 or placebo as nasal spray. Changes in regional brain activity will be quantified by cerebral blood flow and blood oxygenation dependent (BOLD) signal to assess regional brain insulin sensitivity. Brain insulin sensitivity will be compared between eight groups (young normal weight men and women, young overweight/obese men and women, old normal weight men and women, old overweight/obese men and women). Persons are categorized into normal weight and overweight/obese based on the Body Mass Index (BMI). Age groups are build based on a median split.
次要结局
- Correlation with cognitive function(1 hours)
- Whole-body insulin sensitivity(2 hours)
- Correlation with autonomous nervous system activity(10 - 150 minutes post nasal spray)
- Response to food cues(20 minutes)
