Clinical trial NCT06552130: The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
Official title: The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Sensitivity
Keywords: brain insulin action
autonomic nervous system
physical activity
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* BMI \< 24 kg/m2
* no known primary diseases
* hormonal contraception with a single-phase preparation

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Immune system activation
timeFrame: 120 minutes
measure: Immune system activation
timeFrame: 120 minutes
Secondary outcomes:
measure: Maximal oxygen consumption (VO2max)
timeFrame: 60 minutes
measure: Heart rate variability
timeFrame: 120 minutes
measure: Corticotropic pituitary axis modulation
timeFrame: 120 minutes
measure: Leukocyte gene expression
timeFrame: 120 minutes
measure: Individual anaerobic threshold
timeFrame: 120 minutes
measure: Catecholamines
timeFrame: 120 minutes
measure: Effects on blood coagulation parameters
timeFrame: 120 Minutes
Other outcomes:
measure: sex differences
timeFrame: 120 minutes
Locations:
city: Ulm
country: Germany
facility: Universityhospital Ulm
Study officials:
affiliation: University of Ulm
name: Martin Heni, MD
role: PRINCIPAL_INVESTIGATOR
References: