NCT07466173

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 6, 2026

Last Update Submit

March 11, 2026

Conditions

Insulin Sensitivity

Keywords

brain insulin actionautonomic nervous systemphysical activityimmune system

Outcome Measures

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.

    120 minutes

Secondary Outcomes (7)

  • Maximal oxygen consumption (VO2max)

    60 minutes

  • Heat rate variability

    120 minutes

  • Corticotropic pituitary axis modulation

    120 minutes

  • Leukocyte gene expression

    120 minutes

  • Individual anaerobic threshold

    120 minutes

  • +2 more secondary outcomes

Other Outcomes (2)

  • Sex differences

    120 minutes

  • Differences between lean and overweight persons

    120 minutes

Study Arms (2)

Intranasal Insulin Spray

EXPERIMENTAL

160 Units of human insulin as nasal spray

Other: Spiroergometer test with intranasal insulin spray

Placebo Spray

PLACEBO COMPARATOR

Nasal spray containing placebo solution

Other: Spiroergometer test with intranasal placebo spray

Interventions

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.

Intranasal Insulin Spray
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 Ă— 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.

Placebo Spray

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 28 kg/m2
  • no known primary disease
  • hormonal contraception with a single-phase preparation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulm University Hospital

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Insulin ResistanceMotor Activity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Martin Heni, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Heni, MD

CONTACT

+4973150044505martin.heni@uniklinik-ulm.de

Sabrina Wangler

CONTACT

+4973150044782sabrina.wangler@uniklinik-ulm.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Section Endocrinology and Diabetology, Full Professorship (W3) for Endocrinology and Diabetology

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)