Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
10 participants
OBSERVATIONAL
2023-08-30
2023-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
NCT04450745
Effect of Glycemic Index on Physical Capacity in Runners
NCT03062527
Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
NCT05357534
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes
NCT02039934
Isolated and Combined Effect of a Low Carbohydrate Diet and Exercise in Hypoxia in Patients With Type 2 Diabetes
NCT05094505
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Type 1 diabetes group
Male participants with confirmed T1DM diagnosis for ≥1 year who have completed a marathon.
No interventions assigned to this group
Control Group
Healthy male marathon runners matched by age, sex, and training background
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years.
* Written informed consent and adherence to the study protocol.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Poznan University of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zozulińska-Ziółkiewicz Dorota MD PhD
Head of the Department of Internal Medicine and Diabetology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dorota Zozulinska-Ziolkiewicz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
Poznan, Greater Poland Voivodeship, Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Poznan University of Medical Sciences in Poznań is conducting the project "Development of the University Centre for Sports and Medical Studies in Poznań" (No. NdS/544750/2021/2022), funded by the Ministry of Education and Science under th
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1245/18
Identifier Type: OTHER
Identifier Source: secondary_id
NdS/544750/2021/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.