Type 1 Diabetes MellitusNCT01727661
Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM
An observational study of Type 1 Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- exercise testing with near-infrared spectroscopy, lung function testing and quality of life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: outpatient department
Who may be able to join
- diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)
- age-, gender-, and BMI-matched healthy subjects (control group)
Who cannot join
- cardiac or respiratory disease
- pregnancy
- hospitalization due to any medical condition in recent 6 months
- any other condition affecting exercise performance or lung function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- exercise testing with near-infrared spectroscopy, lung function testing, quality of life
- Keywords
- diabetes mellitus, cardiopulmonary fitness, lung function, muscular oxygenation
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise testing with near-infrared spectroscopyBehavioural
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 testingBehavioural
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 lifeBehavioural
assessing quality of life using short-forum 36 (questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes mellitus | 1. exercise testing with near-infrared spectroscopy
2. lung function testing
3. quality of life Receives: Behavioral: exercise testing with near-infrared spectroscopy; Behavioral: lung function testing; Behavioral: quality of life | |
| healthy controls | 1. exercise testing with near-infrared spectroscopy
2. lung function testing
3. quality of life Receives: Behavioral: exercise testing with near-infrared spectroscopy; Behavioral: lung function testing; Behavioral: quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise testing with near-infrared spectroscopy
Measured: at baseline
Secondary outcomes (2)
lung function
flow volume loop, lung diffusing capacity
Measured: at baseline
quality of life
short-forum 36
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Tai Wu, phD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727661
- Sponsor's protocol ID
- 201201005RIC
- Status last verified
- Mar 2013
- First submitted
- 8 Jul 2012
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1111/j.1464-5491.1992.tb01771.x.
PubMed 1576807Komatsu 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.
PubMed 20807874
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01727661
- Acronym / sponsor ID
- 201201005RIC
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes mellitus, cardiopulmonary fitness, lung function, muscular oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes mellitus | – | Behavioral: exercise testing with near-infrared spectroscopy, Behavioral: lung function testing, Behavioral: quality of life1. exercise testing with near-infrared spectroscopy 2. lung function testing 3. quality of life |
| healthy controls | – | Behavioral: exercise testing with near-infrared spectroscopy, Behavioral: lung function testing, Behavioral: quality of life1. exercise testing with near-infrared spectroscopy 2. lung function testing 3. quality of life |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- outpatient department
Key inclusion criteria (2 listed)
- diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)
- age-, gender-, and BMI-matched healthy subjects (control group)
Key exclusion criteria (4 listed)
- cardiac or respiratory disease
- pregnancy
- hospitalization due to any medical condition in recent 6 months
- any other condition affecting exercise performance or lung function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise testing with near-infrared spectroscopysubjects 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. | Behavioural | healthy controls, type 1 diabetes mellitus |
| lung function testingspirometry 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. | Behavioural | healthy controls, type 1 diabetes mellitus |
| quality of lifeassessing quality of life using short-forum 36 (questionnaire) | Behavioural | healthy controls, type 1 diabetes mellitus |
Primary outcome
exercise testing with near-infrared spectroscopy
Time frame: at baseline
2 secondary outcomes
lung function
Time frame: at baseline
quality of life
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Background: PubMed 1576807Wanke 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. doi: 10.1111/j.1464-5491.1992.tb01771.x.
- Background: PubMed 20807874Komatsu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Tai Wu, phD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise testing with near-infrared spectroscopy (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.