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

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ClinicalTrials.gov Identifier: NCT01727661
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Behavioral: exercise testing with near-infrared spectroscopy Behavioral: lung function testing Behavioral: quality of life

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.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus
Study Start Date : February 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
type 1 diabetes mellitus
  1. exercise testing with near-infrared spectroscopy
  2. lung function testing
  3. quality of life
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)
healthy controls
  1. exercise testing with near-infrared spectroscopy
  2. lung function testing
  3. quality of life
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)



Primary Outcome Measures :
  1. exercise testing with near-infrared spectroscopy [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. lung function [ Time Frame: at baseline ]
    flow volume loop, lung diffusing capacity

  2. quality of life [ Time Frame: at baseline ]
    short-forum 36



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
outpatient department
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727661


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ying-Tai Wu, phD National Taiwan University Hospital

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01727661     History of Changes
Other Study ID Numbers: 201201005RIC
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by National Taiwan University Hospital:
diabetes mellitus
cardiopulmonary fitness
lung function
muscular oxygenation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases