The Importance of Insulin Action in the Brain for the Immune System During Physical Activity

University of Ulm

Status: Enrolling

Conditions: Insulin Sensitivity

Treatments: Other: Spiroergometer test with intranasal placebo spray; Other: Spiroergometer test with intranasal insulin spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06552130

81/24

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Intranasal insulin spray

Experimental group

Description:

160 Units of human insulin as nasal spray

Treatment:

Other: Spiroergometer test with intranasal insulin spray

Placebo spray

Placebo Comparator group

Description:

Nasal spray containing placebo solution

Treatment:

Other: Spiroergometer test with intranasal placebo spray