About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BMI > 28 kg/m2
no known primary disease
hormonal contraception with a single-phase preparation
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
Spiroergometer test with intranasal insulin spray
Other interventionParticipants 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.
Spiroergometer test with intranasal placebo spray
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Maximal oxygen consumption (VO2max)
Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry.
Heat 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.
Corticotropic pituitary axis modulation
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
Leukocyte gene expression
Influence of central nervous insulin action on the gene expression of leukocytes during physical activity
Other outcomes
Sex differences
Potential differences in the above mentioned outcomes between sexes will be analyzed.
Differences between lean and overweight persons
Potential differences in the above mentioned outcomes between lean individuals studied in (NCT06552130) and overweight individuals studied in this trial.
Sponsors and contacts
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