Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552130
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 30 min bicycle spiroergometer test at 80 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 iv 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
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 30 min bicycle spiroergometer test at 80 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 iv 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None