NCT07543705

Brief Summary

As part of the mandatory annual assessment of physical fitness, soldiers are required to complete a standardized military march. A total of 100 healthy volunteer participants will be recruited from soldiers serving at the Bundeswehr Hospital Ulm. During this march, physiological and metabolic parameters will be assessed. At baseline, anthropometric data and information on medical history, lifestyle, and fitness status will be collected, including a validated questionnaire on physical activity. Blood and urine samples will be obtained to determine routine laboratory and metabolic parameters, and body composition will be assessed using bioelectrical impedance analysis. In addition, selected sensors will be applied to continuously record physiological data. Participants will then complete a 6 km march carrying 15 kg of equipment. After completion of the march, sensors will be removed and additional blood and urine samples will be collected to evaluate metabolic responses to physical exertion, including catecholamine levels.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Apr 2026

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

March 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 22, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 16, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

glucose levelsendurance exercisecontinuous glucose monitoring

Outcome Measures

Primary Outcomes (5)

  • Glucose dynamics during exercise

    Interstitial glucose responses during the standardized endurance exercise (6 kilometer march with 15 kilogram load) measured via continuous glucose monitoring.

    1 hour

  • Sympathetic nervous system activation (catecholamines)

    Activation of the sympathetic nervous system during a standardized endurance exercise measured via changes in catecholamine levels.

    Baseline, immediately after the march (approximately 1 hour after baseline)

  • Correlation between sympathetic activation (catecholamines) and glucose dynamics during endurance exercise

    Correlation between sympathetic nervous system activation measured via catecholamine levels and glucose responses during a standardized endurance exercise (6 kilometer march with 15 kilogram load).

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • Heart rate variability

    Heat rate variability during a standardized endurance exercise measured via electrocardiography.

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • Correlation between heart rate variability and glucose dynamics during endurance exercise

    Correlation between heart rate variability and glucose responses during a standardized endurance exercise (6 kilometer march with 15 kilogram load).

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

Secondary Outcomes (10)

  • Training status

    Baseline

  • Correlation between training status and glucose dynamics during endurance exercise

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • Body composition

    Baseline.

  • Correlation between body composition and glucose dynamics during exercise.

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • Biomarkers of inflammatory response

    Baseline and immediately after the march (approximately 1 hour after baseline)

  • +5 more secondary outcomes

Other Outcomes (7)

  • Sex differences in correlation between sympathetic activation (catecholamines) and glucose dynamics during endurance exercise

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • Sex differences in the correlation between heart rate variability and glucose dynamics during endurance exercise

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • Sex differences in the correlation of training status with glucose dynamics during endurance exercise

    Baseline, during the 1 hour-march, immediately after the march (approximately 1 hour after baseline)

  • +4 more other outcomes

Study Arms (1)

Soldiers

healthy volunteer participants recruited from soldiers serving at the Bundeswehr Hospital Ulm

Other: Standardized military march

Interventions

6 km march carrying 15 kg of equipment. The march will be conducted in uniform in accordance with central military regulations. Participants will be equipped with a continuous glucose monitor an electrocardiography wearable during the march. Before and after the march blood and urine samples will be obtained.

Soldiers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteer participants recruited from soldiers serving at the Bundeswehr Hospital Ulm

You may qualify if:

  • BMI between 18.5 and 30 kg/m\^2

You may not qualify if:

  • Pregnancy or lactation
  • cardiovascular disease
  • vegan diet
  • drug or alcohol abuse
  • Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin or influences the autonomic nervous system
  • No consent to be informed about incidentally discovered pathological findings
  • Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundeswehr Hospital Ulm

Ulm, 89081, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

Study Officials

  • Martin Heni, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
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 16, 2026

First Posted

April 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations