An interventional study of Spiroergometer test with intranasal insulin spray and Spiroergometer test with intranasal placebo spray in Insulin Sensitivity, sponsored by University of Ulm. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University of Ulm · Not applicable, Interventional, and Basic science
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.
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
160 Units of human insulin as nasal spray
Other: Spiroergometer test with intranasal insulin spray
Nasal spray containing placebo solution
Other: Spiroergometer test with intranasal placebo spray
Participants will undergo a 60 min bicycle spiroergometer test and intranasal insulin spray. Intranasal insulin will be administered 30 minutes prior to the start of the physical activity.
Participants will undergo a 30 min bicycle spiroergometer test and intranasal placebo spray. To mimic insulin spill-over from nasal spray into systemic circulation, an i.v. insulin bolus of 3 mU × kg-1. will be administered over 15 minutes 30 minutes prior to the start of the physical activity on the placebo spray day. On the insulin spray day a comparable amount of saline will be infused.
Immune system activation
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.
Time frame: 120 minutes
Immune system activation
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.
Time frame: 120 minutes
Maximal oxygen consumption (VO2max)
Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry.
Time frame: 60 minutes
Heart rate variability
Influence of central nervous insulin action on the activity of the autonomic nervous system recorded by means of heart rate variability from an electrocardiogram.
Time frame: 120 minutes
Corticotropic pituitary axis modulation
Influence of central nervous insulin action in the activity of the corticotropin pituitary axis during physical activity, measured by cortisol, dehydroepiandrosterone and adrenocorticotropic hormone
Time frame: 120 minutes
Leukocyte gene expression
Influence of central nervous insulin action on the gene expression of leukocytes during physical activity
Time frame: 120 minutes
Individual anaerobic threshold
Influence of central nervous insulin action on physical performance. Individual anaerobic threshold assessed by lactate measurement from venous blood sampling.
Time frame: 120 minutes
Catecholamines
Influence of central nervous insulin action on the activity of the autonomic nervous system recorded by means of measuring catecholamine concentrations from venous blood.
Time frame: 120 minutes
Effects on blood coagulation parameters
Influence of central nervous insulin action and/or physical activity on blood coagulation parameters assessed through global coagulation tests and single coagulation factors.
Time frame: 120 Minutes
sex differences
Potential differences in the above mentioned outcomes between sexes will be analyzed.
Time frame: 120 minutes
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Ulm