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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727661
• Other study ID #: 201201005RIC
• Status: Completed
• Phase: N/A
• First received: July 8, 2012
• Last updated: March 6, 2013
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise testing with near-infrared spectroscopy		at baseline	No
Secondary	lung function	flow volume loop, lung diffusing capacity	at baseline	No
Secondary	quality of life	short-forum 36	at baseline	No