NCT01727661

Brief Summary

The purpose of this study is to compare the differences of

  1. 1.cardiopulmonary fitness
  2. 2.lung function
  3. 3.muscular oxygen saturation
  4. 4.quality of life between type 1 diabetes mellitus and healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

July 8, 2012

Last Update Submit

March 6, 2013

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes mellituscardiopulmonary fitnesslung functionmuscular oxygenation

Outcome Measures

Primary Outcomes (1)

  • exercise testing with near-infrared spectroscopy

    at baseline

Secondary Outcomes (2)

  • lung function

    at baseline

  • quality of life

    at baseline

Study Arms (2)

type 1 diabetes mellitus

1. exercise testing with near-infrared spectroscopy 2. lung function testing 3. quality of life

Behavioral: exercise testing with near-infrared spectroscopyBehavioral: lung function testingBehavioral: quality of life

healthy controls

1. exercise testing with near-infrared spectroscopy 2. lung function testing 3. quality of life

Behavioral: exercise testing with near-infrared spectroscopyBehavioral: lung function testingBehavioral: quality of life

Interventions

exercise testing with near-infrared spectroscopyBEHAVIORAL

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.

healthy controlstype 1 diabetes mellitus
lung function testingBEHAVIORAL

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.

healthy controlstype 1 diabetes mellitus
quality of lifeBEHAVIORAL

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

healthy controlstype 1 diabetes mellitus

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

outpatient department

You may qualify if:

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

You may not qualify if:

  • cardiac or respiratory disease
  • pregnancy
  • hospitalization due to any medical condition in recent 6 months
  • any other condition affecting exercise performance or lung function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 1576807BACKGROUND

  • 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.

    PMID: 20807874BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Exercise TestSpectroscopy, Near-InfraredQuality of Life

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesDiagnostic ImagingSpectrum AnalysisChemistry Techniques, AnalyticalHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ying-Tai Wu, phD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2012

First Posted

November 16, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

TW(1)