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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Ulm

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI > 28 kg/m2

no known primary disease

hormonal contraception with a single-phase preparation

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Spiroergometer test with intranasal insulin spray

    Other intervention

    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 spray

    Other intervention

    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.

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: Intranasal Insulin SprayExperimental treatment 1 intervention
Group B: Placebo SprayPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
120 minutes

Secondary outcomes

1

Maximal oxygen consumption (VO2max)

Influence of central nervous insulin action on physical performance measured as VO2 peak during spiroergometry.

Time frame
60 minutes
2

Heat 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.

Time frame
120 minutes
3

Corticotropic pituitary axis modulation

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

Time frame
120 minutes
4

Leukocyte gene expression

Influence of central nervous insulin action on the gene expression of leukocytes during physical activity

Time frame
120 minutes

Other outcomes

1

Sex differences

Potential differences in the above mentioned outcomes between sexes will be analyzed.

Time frame
120 minutes
2

Differences between lean and overweight persons

Potential differences in the above mentioned outcomes between lean individuals studied in (NCT06552130) and overweight individuals studied in this trial.

Time frame
120 minutes

Sponsors and contacts

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