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

NCT06552130 | Active Not Recruiting

• 1 other identifier: 81/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Keywords

brain insulin action; autonomic nervous system; physical activity

Outcome Measures

Primary Outcomes (2)

• 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

• Immune system activation

  Influence of central nervous insulin action on the activation of the immune system activation by exercise, measured by the composition of immune cells in circulation and cytokine release in the supernatant of stimulated peripheral blood mononuclear cells.

  120 minutes

Secondary Outcomes (7)

• Maximal oxygen consumption (VO2max)

  60 minutes

• Heart rate variability

  120 minutes

• Corticotropic pituitary axis modulation

  120 minutes

• Leukocyte gene expression

  120 minutes

• Individual anaerobic threshold

  120 minutes

Other Outcomes (1)

• sex differences

  120 minutes

Study Arms (2)

Intranasal insulin spray

EXPERIMENTAL

160 Units of human insulin as nasal spray

Other: Spiroergometer test with intranasal insulin spray

Placebo spray

PLACEBO COMPARATOR

Nasal spray containing placebo solution

Other: Spiroergometer test with intranasal placebo spray

Interventions

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.

Intranasal insulin spray

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.

Placebo spray

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Universityhospital Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Insulin Resistance; Motor Activity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Martin Heni, MD

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Section Endocrinology and Diabetology, Full Professorship (W3) for Endocrinology and Diabetology

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 13, 2024
• Study Start: December 15, 2024
• Primary Completion: August 14, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

DE (1)