Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM - Full Text View

Purpose

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.

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

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1 Exercise and Physical Fitness Oxygen Therapy

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

exercise testing with near-infrared spectroscopy [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

lung function [ Time Frame: at baseline ] [ Designated as safety issue: No ]
flow volume loop, lung diffusing capacity
quality of life [ Time Frame: at baseline ] [ Designated as safety issue: No ]
short-forum 36

Enrollment:	40
Study Start Date:	February 2012
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
type 1 diabetes mellitus exercise testing with near-infrared spectroscopy lung function testing 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 exercise testing with near-infrared spectroscopy lung function testing 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)

Groups/Cohorts

Assigned Interventions

type 1 diabetes mellitus

exercise testing with near-infrared spectroscopy
lung function testing
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

exercise testing with near-infrared spectroscopy
lung function testing
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)

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.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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.

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. Epub 2010 Aug 31.

Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01727661 History of Changes
Other Study ID Numbers:	201201005RIC
Study First Received:	July 8, 2012
Last Updated:	March 6, 2013
Health Authority:	Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 19, 2013