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临床试验/NCT06935903
NCT06935903已完成不适用

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

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年8月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
VO₂max (mL/kg/min)

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

VO₂max (mL/kg/min)

时间窗: single visit

peak oxygen uptake during graded exercise testing

次要结局

  • Lean tissue percentage [%](single visit)
  • Resting metabolic rate (kcal/day)(single visit)
  • Body adipose percentage [%](single visit)
  • Forced Vital Capacity [L](single visit)
  • Maximum Vital Capacity [L](single visit)
  • Forced Expiratory Volume in 1 second [%](single visit)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zozulińska-Ziółkiewicz Dorota MD PhD

Head of the Department of Internal Medicine and Diabetology

Poznan University of Medical Sciences

研究点 (1)

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