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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin Spray | Experimental | 160 Units of human insulin as nasal spray |
|
| Placebo Spray | Placebo Comparator | Nasal spray containing placebo solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiroergometer test with intranasal insulin spray | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen consumption (VO2max) | Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry. | 60 minutes |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sex differences | Potential differences in the above mentioned outcomes between sexes will be analyzed. | 120 minutes |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Heni, MD | Contact | +4973150044505 | martin.heni@uniklinik-ulm.de | |
| Sabrina Wangler | Contact | +4973150044782 | sabrina.wangler@uniklinik-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Martin Heni, MD | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulm University Hospital | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Spiroergometer test with intranasal placebo spray | Other | 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. |
|
| 120 minutes |
| 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 | 120 minutes |
| Leukocyte gene expression | Influence of central nervous insulin action on the gene expression of leukocytes during physical activity | 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. | 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. | 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. | 120 minutes |
| 120 minutes |
| D001519 | Behavior |