Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM

Study Overview
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Brief Summary
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The purpose of this study is to compare the differences of cardiopulmonary fitness lung function muscular oxygen saturation quality of life between type 1 diabetes mellitus and healthy adults.

Detailed Description
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This study is also to investigate the relationships between cardiopulmonary fitness, lung function, muscular oxygen saturation, glycemic control, and quality of life in patients with type 1 diabetes mellitus.

Official Title
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Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: exercise testing with near-infrared spectroscopy
* Behavioral: lung function testing
* Behavioral: quality of life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group) age-, gender-, and BMI-matched healthy subjects (control group) Exclusion Criteria: cardiac or respiratory disease pregnancy hospitalization due to any medical condition in recent 6 months any other condition affecting exercise performance or lung function.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 1 diabetes mellitus<br>exercise testing with near-infrared spectroscopy lung function testing quality of life | Behavioral: exercise testing with near-infrared spectroscopy<br>* subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.<br>Behavioral: lung function testing<br>* spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation. single-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds.<br>Behavioral: quality of life<br>* assessing quality of life using short-forum 36 (questionnaire)<br>|
| healthy controls<br>exercise testing with near-infrared spectroscopy lung function testing quality of life | Behavioral: exercise testing with near-infrared spectroscopy<br>* subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.<br>Behavioral: lung function testing<br>* spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation. single-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds.<br>Behavioral: quality of life<br>* assessing quality of life using short-forum 36 (questionnaire)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise testing with near-infrared spectroscopy |  | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function | flow volume loop, lung diffusing capacity | at baseline | 
| quality of life | short-forum 36 | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, cardiopulmonary fitness, lung function, muscular oxygenation