- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01727661
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
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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-
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Taipei, Taiwan, 100
- National Taiwan University Hospital
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
type 1 diabetes mellitus
|
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.
assessing quality of life using short-forum 36 (questionnaire)
|
|
healthy controls
|
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.
assessing quality of life using short-forum 36 (questionnaire)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
exercise testing with near-infrared spectroscopy
Zeitfenster: at baseline
|
at baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
lung function
Zeitfenster: at baseline
|
flow volume loop, lung diffusing capacity
|
at baseline
|
|
quality of life
Zeitfenster: at baseline
|
short-forum 36
|
at baseline
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ying-Tai Wu, phD, National Taiwan University Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 201201005RIC
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