Insulin SensitivityNCT06552130
The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
A study testing Spiroergometer test with intranasal insulin spray in people with Insulin Sensitivity, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Spiroergometer test with intranasal insulin spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 24 kg/m2
- no known primary diseases
- hormonal contraception with a single-phase preparation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Insulin Sensitivity
- Being tested
- Spiroergometer test with intranasal insulin spray, Spiroergometer test with intranasal placebo spray
- Keywords
- brain insulin action, autonomic nervous system, physical activity
- Medical subject headings
- Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiroergometer test with intranasal insulin sprayOther
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.
Spiroergometer test with intranasal placebo sprayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal insulin spray | Experimental | 160 Units of human insulin as nasal spray Receives: Other: Spiroergometer test with intranasal insulin spray |
| Placebo spray | Placebo comparator | Nasal spray containing placebo solution Receives: Other: Spiroergometer test with intranasal placebo spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 120 minutes
Secondary outcomes (7)
Maximal oxygen consumption (VO2max)
Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry.
Measured: 60 minutes
Heart 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.
Measured: 120 minutes
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
Measured: 120 minutes
Leukocyte gene expression
Influence of central nervous insulin action on the gene expression of leukocytes during physical activity
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start15 Dec 2024
- Primary completion14 Aug 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Heni, University of Ulm
- Investigators
- Martin Heni, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552130
- Sponsor's protocol ID
- 81/24
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Insulin Action in the Brain for the Immune System During Physical Activity
- ClinicalTrials.gov ID
- NCT06552130
- Acronym / sponsor ID
- 81/24
- Conditions
- Insulin Sensitivity
- Keywords
- brain insulin action, autonomic nervous system, physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal insulin spray | Experimental | Other: Spiroergometer test with intranasal insulin spray160 Units of human insulin as nasal spray |
| Placebo spray | Placebo comparator | Other: Spiroergometer test with intranasal placebo sprayNasal spray containing placebo solution |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI < 24 kg/m2
- no known primary diseases
- hormonal contraception with a single-phase preparation
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiroergometer test with intranasal insulin sprayParticipants 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. | Other | Intranasal insulin spray |
| Spiroergometer test with intranasal placebo sprayParticipants 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. | Other | Placebo spray |
Primary outcome
Immune system activation
Time frame: 120 minutes
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.
Immune system activation
Time frame: 120 minutes
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.
7 secondary outcomes
Maximal oxygen consumption (VO2max)
Time frame: 60 minutes
Heart rate variability
Time frame: 120 minutes
Corticotropic pituitary axis modulation
Time frame: 120 minutes
Leukocyte gene expression
Time frame: 120 minutes
Individual anaerobic threshold
Time frame: 120 minutes
Catecholamines
Time frame: 120 minutes
Effects on blood coagulation parameters
Time frame: 120 Minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Heni, MD principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiroergometer test with intranasal insulin spray in people with Insulin Sensitivity, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune system activation (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.