The Importance of Insulin Action in the Brain for the Immune System During Physical Activity-Overweight
NCT07466173 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-03-16
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. 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.
Conditions
- Insulin Sensitivity
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.
Sponsors & Collaborators
-
University of Ulm
lead OTHER
Principal Investigators
-
Martin Heni, MD · University of Ulm
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
Countries
- Germany
Study Locations
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