Skip to content

Marathon Runners With Type 1 Diabetes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06935903
Enrollment
10
Registered
2025-04-20
Start date
2023-08-30
Completion date
2023-10-22
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 Diabetes, Physical Activity, Physical Endurance, Absorptiometry, Oxygen Consumption

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

Detailed description

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).

Interventions

None listed

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
VO₂max (mL/kg/min)single visitpeak oxygen uptake during graded exercise testing

Secondary

MeasureTime frameDescription
Body adipose percentage [%]single visitThe proportion of a person's total body mass that is composed of adipose tissue, assessed using dual-energy X-ray absorptiometry (DXA).
Lean tissue percentage [%]single visitThe proportion of a person's total body mass that is composed of lean tissue, assessed using dual-energy X-ray absorptiometry (DXA).
Resting metabolic rate (kcal/day)single visitThe amount of energy expended by the body at rest in a fasting state, measured in kilocalories per day using indirect calorimetry.
Maximum Vital Capacity [L]single visitthe greatest volume of air that can be exhaled after a maximal inhalation, measured in liters.
Forced Expiratory Volume in 1 second [%]single visitthe percentage of the Forced Vital Capacity that is exhaled during the first second of a forced breath, indicating airway function
Forced Vital Capacity [L]single visitthe total volume of air exhaled forcefully after a full inhalation, measured in liters.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026