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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: exercise testing with near-infrared spectroscopy; Behavioral: lung function testing; Behavioral: quality of life

• Registration Number: NCT01727661
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)
• age-, gender-, and BMI-matched healthy subjects (control group)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
exercise testing with near-infrared spectroscopy	at baseline

Secondary Outcome Measures

Name	Time	Method
lung function	at baseline	flow volume loop, lung diffusing capacity
quality of life	at baseline	short-forum 36

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan