The Importance of Insulin Action in the Brain for the Immune System During Physical Activity-Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spiroergometer test with intranasal insulin spray, Spiroergometer test with intranasal placebo spray.
- Who it may be relevant to
- Registry conditions: Insulin Sensitivity. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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. In another trial (NCT06552130) lean participants already have been tested. Significant effects on circulating cytokines could be identified. In this amendment, overweight persons in which brain insulin resistance is expected will be tested.
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 and investigate whether participants with overweight respond different compared to lean persons. The lean persons were already studied in another trial (NCT06552130) and this trial serves as an amendment.
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.
Interventions
- Other Spiroergometer test with intranasal insulin spray
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. - Other Spiroergometer test with intranasal placebo spray
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.
Primary outcome measures
- Immune system activation [Time frame: 120 minutes]
Secondary outcome measures (7)
- Maximal oxygen consumption (VO2max) [Time frame: 60 minutes]
- Heat 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]
Eligibility criteria
Inclusion criteria
- BMI > 28 kg/m2
- no known primary disease
- hormonal contraception with a single-phase preparation
Exclusion criteria
- alcohol or drug abuse
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Ulm University Hospital — Ulm
Identifiers
NCT: NCT07466173 · 81/24 Amendment