The Importance of Insulin Action in the Brain for the Immune System During Physical Activity-Overweight
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Immune system activation
研究概览
简要总结
The goal of this clinical trial is to clarify the interaction of central insulin action and physical activity with the immune system. Therefore, participants will undergo bicycle spiroergometer tests. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray. In another trial (NCT06552130) lean participants already have been tested. Significant effects on circulating cytokines could be identified. In this amendment, overweight persons in which brain insulin resistance is expected will be tested.
详细描述
This research project aims to investigate if the brain insulin action regulates the immune system via the autonomous nervous system during physical activity and investigate whether participants with overweight respond different compared to lean persons. The lean persons were already studied in another trial (NCT06552130) and this trial serves as an amendment.
Insulin action in the brain will be introduced by application of insulin as nasal spray (on one day) versus carrier solution as placebo nasal spray (on another day) in a randomized, blinded fashion. Spray administration will be performed 30 minutes before a 60 min bicycle spiroergometer test at 70 % VO2max that will introduce a postprandial state. On placebo day, the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate i.v. insulin bolus. Using this approach, brain-derived regulation of the immune system including the stimulation of immune cells via cytokines, physical performance, activity of the autonomous nervous system and gene-expression of leukocytes will be examined.
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
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 28 kg/m2
- •no known primary disease
- •hormonal contraception with a single-phase preparation
排除标准
- •alcohol or drug abuse
- •At screening: Hb < 12 g/dl for women and Hb < 14 g/dl for men
- •Any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.
研究组 & 干预措施
Intranasal Insulin Spray
160 Units of human insulin as nasal spray
干预措施: Spiroergometer test with intranasal insulin spray (Other)
Placebo Spray
Nasal spray containing placebo solution
干预措施: Spiroergometer test with intranasal placebo spray (Other)
结局指标
主要结局
Immune system activation
时间窗: 120 minutes
Influence of central nervous insulin action on the activation of the immune system activation by exercise, measured by circulating cytokines and cytokines in the supernatant of stimulated peripheral blood mononuclear cells.
次要结局
- Maximal oxygen consumption (VO2max)(60 minutes)
- Heat rate variability(120 minutes)
- Corticotropic pituitary axis modulation(120 minutes)
- Leukocyte gene expression(120 minutes)
- Individual anaerobic threshold(120 minutes)
- Catecholamines(120 minutes)
- Effects on blood coagulation parameters(120 minutes)
研究者
Martin Heni
Head of the Section Endocrinology and Diabetology, Full Professorship (W3) for Endocrinology and Diabetology
University of Ulm