Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01727661
Enrollment
40
Registered
2012-11-16
Start date
2012-02-29
Completion date
2013-01-31
Last updated
2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes mellitus, cardiopulmonary fitness, lung function, muscular oxygenation

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.

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

BEHAVIORALexercise 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.

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.

BEHAVIORALquality of life

assessing quality of life using short-forum 36 (questionnaire)

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
exercise testing with near-infrared spectroscopyat baseline

Secondary

MeasureTime frameDescription
lung functionat baselineflow volume loop, lung diffusing capacity
quality of lifeat baselineshort-forum 36

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026