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NCT Number: NCT06935903

Marathon Runners With Type 1 Diabetes

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Poznan, Greater Poland Voivodeship, 60-834, Poland

About this study

This observational, cross-sectional case-control study aims to compare physical capacity and metabolic parameters between male marathon runners with type 1 diabetes mellitus (T1DM) and healthy male marathon runners without diabetes. The study focuses on evaluating differences in cardiopulmonary fitness, resting metabolic rate, and body composition between the two groups.

Participants attended a single study visit after overnight fasting. The visit included anthropometric measurements, assessment of medical history, and structured questionnaires on diabetes management (for T1DM participants) and physical activity habits. Body composition was assessed using dual-energy X-ray absorptiometry (DXA), providing detailed analysis of total and regional fat mass, lean tissue mass, and bone mineral density. Daily calibration of the DXA scanner ensured data accuracy and consistency.

Resting metabolic rate (RMR) was measured by indirect calorimetry using a ventilated hood system. Measurements were performed in a controlled environment with standardized temperature and low light to minimize variability. Data collection spanned 25 minutes, with the first 5 minutes discarded for acclimatization and the subsequent 20 minutes analyzed. Energy expenditure and substrate oxidation rates were calculated using established equations (Weir equation and Zuntz table).

Cardiorespiratory fitness was assessed through a maximal exercise test on a cycle ergometer with continuous respiratory gas analysis. The test protocol began with a resting phase and warm-up, followed by incremental workload increases until volitional exhaustion. Parameters such as VO₂max, ventilatory efficiency, gas exchange threshold, and peak workload were measured using a calibrated metabolic cart.

Data analysis involved descriptive statistics, Mann-Whitney U tests for numerical comparisons, and Chi-square tests for categorical variables. Dedicated manufacturer software was used for CPET data processing, and statistical analyses were conducted using R software (version 4.4.1).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. VO₂max (mL/kg/min)

    Time frame: single visit

    peak oxygen uptake during graded exercise testing

Secondary outcomes

  1. Resting metabolic rate (kcal/day)

    Time frame: single visit

    The amount of energy expended by the body at rest in a fasting state, measured in kilocalories per day using indirect calorimetry.

  2. Body adipose percentage [%]

    Time frame: single visit

    The proportion of a person's total body mass that is composed of adipose tissue, assessed using dual-energy X-ray absorptiometry (DXA).

  3. Lean tissue percentage [%]

    Time frame: single visit

    The proportion of a person's total body mass that is composed of lean tissue, assessed using dual-energy X-ray absorptiometry (DXA).

  4. Forced Vital Capacity [L]

    Time frame: single visit

    the total volume of air exhaled forcefully after a full inhalation, measured in liters.

  5. Maximum Vital Capacity [L]

    Time frame: single visit

    the greatest volume of air that can be exhaled after a maximal inhalation, measured in liters.

  6. Forced Expiratory Volume in 1 second [%]

    Time frame: single visit

    the percentage of the Forced Vital Capacity that is exhaled during the first second of a forced breath, indicating airway function

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Assessment of Physical Capacity and Metabolic Parameters in Marathon Runners With Type 1 Diabetes: an Observational Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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