NCT06935903

Brief Summary

The goal of this observational study is to learn about the physical capacity and metabolic characteristics of male marathon runners with type 1 diabetes mellitus (T1DM). The main question it aims to answer is: Do male marathon runners with T1DM have different physical fitness and metabolic profiles compared to healthy runners without diabetes? Participants with T1DM and healthy controls who have completed a marathon will undergo a single in-person assessment, including body composition analysis, resting metabolic rate measurement, and a maximal exercise test

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 13, 2025

Last Update Submit

April 13, 2025

Conditions

Keywords

Type 1 DiabetesPhysical ActivityPhysical EnduranceAbsorptiometryOxygen Consumption

Outcome Measures

Primary Outcomes (1)

  • VO₂max (mL/kg/min)

    peak oxygen uptake during graded exercise testing

    single visit

Secondary Outcomes (6)

  • Resting metabolic rate (kcal/day)

    single visit

  • Body adipose percentage [%]

    single visit

  • Lean tissue percentage [%]

    single visit

  • Forced Vital Capacity [L]

    single visit

  • Maximum Vital Capacity [L]

    single visit

  • +1 more secondary outcomes

Study Arms (2)

Type 1 diabetes group

Male participants with confirmed T1DM diagnosis for ≥1 year who have completed a marathon.

Control Group

Healthy male marathon runners matched by age, sex, and training background

Eligibility Criteria

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

Adult marathon runners aged ≥18 years. Participants in the T1DM group with a confirmed diagnosis of T1DM for at least one year. The control group comprises healthy people with similar physical activity levels but no chronic health conditions.

You may qualify if:

  • A diagnosis of T1DM for at least 1 year.
  • Age ≥ 18 years.
  • Written informed consent and adherence to the study protocol.

You may not qualify if:

  • Pregnancy.
  • Use of medications significantly affecting metabolism or exercise performance
  • Presence of chronic medical or psychiatric conditions limiting safe participation
  • Presence of advanced chronic complications of diabetes: proliferative retinopathy, diabetic kidney disease in stages III-V, cardiovascular diseases
  • Inability to safely complete maximal exercise testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

Poznan, Greater Poland Voivodeship, 60-834, Poland

Location

Related Publications (7)

  • Shepherd JA, Ng BK, Sommer MJ, Heymsfield SB. Body composition by DXA. Bone. 2017 Nov;104:101-105. doi: 10.1016/j.bone.2017.06.010. Epub 2017 Jun 16.

    PMID: 28625918BACKGROUND
  • Achamrah N, Delsoglio M, De Waele E, Berger MM, Pichard C. Indirect calorimetry: The 6 main issues. Clin Nutr. 2021 Jan;40(1):4-14. doi: 10.1016/j.clnu.2020.06.024. Epub 2020 Jul 2.

    PMID: 32709554BACKGROUND
  • Poole DC, Wilkerson DP, Jones AM. Validity of criteria for establishing maximal O2 uptake during ramp exercise tests. Eur J Appl Physiol. 2008 Mar;102(4):403-10. doi: 10.1007/s00421-007-0596-3. Epub 2007 Oct 30.

    PMID: 17968581BACKGROUND
  • Thuillier P, Domun N, Sonnet E, Le Ven F, Roudaut C, Kergus A, Kerlan V, Roudaut N. Prevention of exercise-induced hypoglycemia in 12 patients with type 1 diabetes running the Paris Marathon using continuous glucose monitoring: A prospective, single-center observational study. Diabetes Metab. 2022 Mar;48(2):101321. doi: 10.1016/j.diabet.2022.101321. Epub 2022 Jan 12.

    PMID: 35032674BACKGROUND
  • Grimm JJ, Muchnick S. Type I diabetes and marathon running. Diabetes Care. 1993 Dec;16(12):1624. doi: 10.2337/diacare.16.12.1624a. No abstract available.

    PMID: 8299461BACKGROUND
  • Riddell MC, Scott SN, Fournier PA, Colberg SR, Gallen IW, Moser O, Stettler C, Yardley JE, Zaharieva DP, Adolfsson P, Bracken RM. The competitive athlete with type 1 diabetes. Diabetologia. 2020 Aug;63(8):1475-1490. doi: 10.1007/s00125-020-05183-8. Epub 2020 Jun 12.

    PMID: 32533229BACKGROUND
  • Chimen M, Kennedy A, Nirantharakumar K, Pang TT, Andrews R, Narendran P. What are the health benefits of physical activity in type 1 diabetes mellitus? A literature review. Diabetologia. 2012 Mar;55(3):542-51. doi: 10.1007/s00125-011-2403-2. Epub 2011 Dec 22.

    PMID: 22189486BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Dorota Zozulinska-Ziolkiewicz, MD, PhD

    Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Internal Medicine and Diabetology

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 20, 2025

Study Start

August 30, 2023

Primary Completion

October 22, 2023

Study Completion

October 22, 2023

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to the small sample size and the potential risk of participant re-identification, even with de-identified data. The study was not designed with broad data sharing in mind, and no participant consent was obtained for public data release.

Locations