Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in endogenous glucose production from before to after nasal spray application in lean persons
研究概览
简要总结
Research in animals and first experiments in humans indicate that insulin action in the brain regulates peripheral insulin sensitivity. One major organ might be the liver. Previous studies in humans showed that the human brain is an insulin sensitive organ in lean but not in overweight/obese persons. Therefore, this study will include lean versus overweight/obese persons.
In this study, insulin action will be introduced by intranasal insulin administration in lean and overweight humans. As a control, placebo spray will be administered. To mimick the known spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin will be administered over 15 minutes following placebo spray application.
Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp and glucose uptake and endogenous glucose production will be assessed by tracer dilution technique. Autonomous nervous system activity will be addressed by heart rate variability. Involved brain areas will be addressed by fMRI before and after nasal insulin application.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers (lean or overweight/obese)
- •HbA1c <6.0%
- •Age between 18 and 40 years
- •healthy as assessed by physician
- •Understanding the explanations about the study and instructions
排除标准
- •non-removable metal parts in or on the body
- •Persons with reduced temperature sensation and / or increased sensitivity to warming of the body
- •Cardiovascular disease can not be excluded, such as evident coronary heart disease, congestive heart failure NYHA greater than 2, history of coronary artery disease
- •History of stroke
- •Persons with a hearing disorder or increased sensitivity to loud noises
- •People with claustrophobia
- •Subjects in which less than 3 months have passed since surgery
- •Simultaneous participation in other studies
- •Acute disease or infection within the last 4 weeks
- •Neurological and psychiatric disorders
- •Subjects with hemoglobin Hb <13g / dl
- •Heparin-induced thrombocytopenia people with a (HIT) in prehistory
- •Allergies to any of the used solutions/devices
研究组 & 干预措施
insulin nasal spray
160 Units of human insulin as nasal spray
干预措施: human insulin (Drug)
placebo nasal spray
Nasal spray containing placebo solution
干预措施: human insulin (Drug)
结局指标
主要结局
Change in endogenous glucose production from before to after nasal spray application in lean persons
时间窗: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min
Will be assessed by tracer dilution technique.
Change in glucose infusion rate during hyperinsulinemic euglycemic glucose clamp from before to after nasal spray application in lean persons
时间窗: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min
Differences in insulin response between lean and overweight persons
时间窗: up to 210 minutes post nasal spray administration
Will be assessed as plasma insulin and C-peptide concentrations.
次要结局
- Autonomous nervous system activity(baseline, 70-90 min, 170-210 min and 280-300 min)
- Regional brain insulin sensitivity(30 min)