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

Overview

The purpose of this study is to compare the differences of 1. cardiopulmonary fitness 2. lung function 3. muscular oxygen saturation 4. quality of life between type 1 diabetes mellitus and healthy adults.

Full Title of Study: “Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: January 2013

Detailed Description

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.

Interventions

  • Behavioral: exercise testing with near-infrared spectroscopy
    • 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.
  • Behavioral: lung function testing
    • 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.
  • Behavioral: quality of life
    • assessing quality of life using short-forum 36 (questionnaire)

Arms, Groups and Cohorts

  • type 1 diabetes mellitus
    • exercise testing with near-infrared spectroscopy lung function testing quality of life
  • healthy controls
    • exercise testing with near-infrared spectroscopy lung function testing quality of life

Clinical Trial Outcome Measures

Primary Measures

  • exercise testing with near-infrared spectroscopy
    • Time Frame: at baseline

Secondary Measures

  • lung function
    • Time Frame: at baseline
    • flow volume loop, lung diffusing capacity
  • quality of life
    • Time Frame: at baseline
    • short-forum 36

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ying-Tai Wu, phD, Principal Investigator, National Taiwan University Hospital

References

Wanke T, Formanek D, Auinger M, Zwick H, Irsigler K. Pulmonary gas exchange and oxygen uptake during exercise in patients with type 1 diabetes mellitus. Diabet Med. 1992 Apr;9(3):252-7. doi: 10.1111/j.1464-5491.1992.tb01771.x.

Komatsu WR, Barros Neto TL, Chacra AR, Dib SA. Aerobic exercise capacity and pulmonary function in athletes with and without type 1 diabetes. Diabetes Care. 2010 Dec;33(12):2555-7. doi: 10.2337/dc10-0769. Epub 2010 Aug 31.

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