"Effect of Central Insulin Administration on Whole-body Insulin Sensitivity in Women"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in the peripheral insulin sensitivity
研究概览
简要总结
The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.
In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.
These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.
详细描述
"Effect of central insulin administration on whole-body insulin sensitivity in women" The human brain is an insulin sensitive organ. Brain insulin action modulates peripheral insulin sensitivity in young lean men. As a underlying mechanism, the investigators previously detected suppression of endogenous glucose production and stimulation of glucose disappearance to peripheral tissue in response to brain insulin delivery by nasal spray. Whether this holds true in young woman is unknown, since differences in brain insulin response between sexes have been reported. The investigators will address this question by combining the delivery of insulin to the brain as nasal spray with hyperinsulinemic euglycemic clamp experiments in natural cycling women.
In the planned randomized, placebo controlled cross-over study, female participants will undergo four hyperinsulinemic euglycemic experiments with tracer dilution, two in the first phase and two in the second phase of their menstrual cycle. On one of the study days per menstrual phase, subjects will receive intranasal insulin administration, on the other placebo spray. The protocol has been successfully applied previously in men. Based on the results of this trial, the investigators calculated a required sample size of N=10 for the planned study in women.
These experiments will help to better understand the role of brain insulin action in a broader sense. The results can be the basis for larger clinical trials that address the sex-specific impact of brain insulin resistance for glucose metabolism and diabetes risk.
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 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female volunteer adults
- •HbA1c <6.0%
- •Age between 18 and 30 years
- •Standard routine laboratory
- •No underlying diseases
- •No medication
- •No hormonal contraception
- •Understanding of the explanations of the study and the instructions
排除标准
- •Persons with limited temperature perception and / or increased temperature Sensitivity to warming of the body
- •Cardiovascular disease, such as manifest coronary Heart disease, heart failure greater than NYHA 2, recent myocardial infarction
- •People with a hearing disorder or increased sensitivity to loud Sounds
- •persons with claustrophobia
- •Minors or non-consenting subjects are also excluded
- •Pregnancy or breastfeeding women
- •Surgery less than 3 months ago
- •Simultaneous participation in other interventional studies
- •Acute illness or infection within the last 4 weeks
- •Neurological and psychiatric disorders
- •Subjects with hemoglobin Hb <12g / dl (at screening)
- •Allergic diseases
- •Individuals with a history of heparin-induced thrombocytopenia (HIT)
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 spray (Drug)
结局指标
主要结局
Change in the peripheral insulin sensitivity
时间窗: 60-90 minutes and 150-210 minutes during euglycemic clamp
Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by euglycemic hyperinsulinemic clamp.
次要结局
- Correlation with autonomous nervous system activity(70-80 minutes and 190-200 minutes during euglycemic clamp)
- Differential effects dependent on female sexual hormones(60-90 minutes and 150-210 minutes during euglycemic clamp)
- Effect of menstrual cycle on insulin sensitivity before spray application(60-90minutes)
- Effect of menstrual cycle on brain insulin sensitivity(60-90 minutes)
- Effect of menstrual cycle on processing of food cues in the brain(20 minutes)