The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
- Conditions
- Insulin Sensitivity
- Interventions
- Other: Spiroergometer test with intranasal placebo sprayOther: Spiroergometer test with intranasal insulin spray
- Registration Number
- NCT06552130
- Lead Sponsor
- University of Ulm
- Brief Summary
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.
- Detailed Description
This research project aims to investigate if the brain insulin action regulates the immune system via the autonomous nervous system during physical activity.
Therefore, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- BMI < 24 kg/m2
- no known primary diseases
- hormonal contraception with a single-phase preparation
- Alcohol or drug abuse
- Smoking
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo spray Spiroergometer test with intranasal placebo spray Nasal spray containing placebo solution Intranasal insulin spray Spiroergometer test with intranasal insulin spray 160 Units of human insulin as nasal spray
- Primary Outcome Measures
Name Time Method Immune system activation 120 minutes Influence of central nervous insulin action on the activation of the immune system activation by exercise, measured by the composition of immune cells in circulation and cytokine release in the supernatant of stimulated peripheral blood mononuclear cells.
- Secondary Outcome Measures
Name Time Method Maximal oxygen consumption (VO2max) 60 minutes Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry.
Heart rate variability 120 minutes Influence of central nervous insulin action on the activity of the autonomic nervous system recorded by means of heart rate variability from an electrocardiogram.
Corticotropic pituitary axis modulation 120 minutes Influence of central nervous insulin action in the activity of the corticotropin pituitary axis during physical activity, measured by cortisol, dehydroepiandrosterone and adrenocorticotropic hormone
Leukocyte gene expression 120 minutes Influence of central nervous insulin action on the gene expression of leukocytes during physical activity
Individual anaerobic threshold 120 minutes Influence of central nervous insulin action on physical performance. Individual anaerobic threshold assessed by lactate measurement from venous blood sampling.
Catecholamines 120 minutes Influence of central nervous insulin action on the activity of the autonomic nervous system recorded by means of measuring catecholamine concentrations from venous blood.
Effects on blood coagulation parameters 120 Minutes Influence of central nervous insulin action and/or physical activity on blood coagulation parameters assessed through global coagulation tests and single coagulation factors.
Trial Locations
- Locations (1)
Universityhospital Ulm
🇩🇪Ulm, Germany