Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07466173

Opening soonNot applicableInterventional

What this study is 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. 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 30 Years
SexAll
Healthy volunteersAccepted
ConditionInsulin Sensitivity

Full registry 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.

Treatments and study arms

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.

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.

Primary outcomes

Immune system activation120 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ulm University Hospital🇩🇪 Ulm, Germany
Sabrina WanglerContact
Kathrin Popp, MDContact