Postmenopausal DiabetesNCT00905203
Effects of Different Exercise Training Dose on Exercise Performance and Noninvasively Estimated Muscle Oxygen Extraction in Diabetic Postmenopausal Women
A study testing exercise in people with Postmenopausal Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is specifically to investigate (1) the exercising muscle oxygenation response in diabetic postmenopausal women; (2) the dose-response of different physical activity interventions on skeletal muscle oxygenation response; (3) the related mechanisms of training effects. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Diabetes
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Feb 2011
- Phase
- Interventional
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary postmenopausal women
- Ages 45 to 70 years old
Who cannot join
- Known cardio-respiratory disease
- Diabetic complication
- Excessive weight change during last year
- Cancer and mental disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Ying-Tai Wu, Ph.D, +886-2-33668129, ytw@ntu.edu.tw
About this study
The purpose of this study is specifically to investigate (1) the exercising muscle oxygenation response in diabetic postmenopausal women; (2) the dose-response of different physical activity interventions on skeletal muscle oxygenation response; (3) the related mechanisms of training effects.
- Conditions
- Postmenopausal Diabetes
- Being tested
- exercise
- Keywords
- Postmenopausal women, Diabetes, Skin microcirculation, Exercise capacity, Skeletal muscle oxygenation, Dose-response relationship, postmenopausal diabetic women
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
exercise training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | moderate exercise training (three times/ week including one home-based training and two supervised training) Receives: Other: exercise |
| 2 | Experimental | intensive exercise training (four times/ week including one home-based training and three supervised training) Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal muscle oxygenation response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ying-Tai Wu, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905203
- Sponsor's protocol ID
- 200811009R
- Status last verified
- Jun 2010
- First submitted
- 18 May 2009
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Exercise Training Dose on Exercise Performance and Noninvasively Estimated Muscle Oxygen Extraction in Diabetic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00905203
- Acronym / sponsor ID
- 200811009R
- Conditions
- Postmenopausal Diabetes
- Keywords
- Postmenopausal women, Diabetes, Skin microcirculation, Exercise capacity, Skeletal muscle oxygenation, Dose-response relationship, postmenopausal diabetic women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 20 May 2009 (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 specifically to investigate (1) the exercising muscle oxygenation response in diabetic postmenopausal women; (2) the dose-response of different physical activity interventions on skeletal muscle oxygenation response; (3) the related mechanisms of training effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: exercisemoderate exercise training (three times/ week including one home-based training and two supervised training) |
| 2 | Experimental | Other: exerciseintensive exercise training (four times/ week including one home-based training and three supervised training) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sedentary postmenopausal women
- Ages 45 to 70 years old
Key exclusion criteria (4 listed)
- Known cardio-respiratory disease
- Diabetic complication
- Excessive weight change during last year
- Cancer and mental disorders
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 |
|---|---|---|
| exerciseexercise training | Other | 1, 2 |
Primary outcome
skeletal muscle oxygenation response
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
Related trials for Postmenopausal Diabetes
Active, not recruiting
Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Overweight/Obesity and Impaired Glucose Homeostasis
Menopause, Type 2 Diabetes
Not yet recruiting
Functional Mobility and Resistance Exercise for Postmenopausal Females With Type 1 Diabetes
Type 1 Diabetes (T1D), Menopause
Recruiting
Circadian Rhythms in Postmenopausal Women
Metabolic Syndrome, Postmenopausal Symptoms
Not yet recruiting
Chrono-restricted Diet and Physical Activity as a New Preventive Strategy for Sarcopenia in Postmenopausal Women With Obesity and Type 2 Diabetes
Obesity, Sarcopenia
Recruiting
Exercise Training and Fat Metabolism in Postmenopausal Women
Postmenopausal Symptoms, Obesity
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, Ph.D 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?
A study testing exercise in people with Postmenopausal Diabetes, 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: status not confirmed, as of the sponsor's last update on 15 Jul 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Tai Wu, Ph.D (+886-2-33668129, ytw@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal muscle oxygenation response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2010.