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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033649
Receipt No. R000038276
Scientific Title To investigate of optinum exercise intensity in type 2 diabetes mellitus -validity of double product break point method-
Date of disclosure of the study information 2018/08/20
Last modified on 2020/03/27

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Basic information
Public title To investigate of optinum exercise intensity in type 2 diabetes mellitus -validity of double product break point method-
Acronym To investigate of optinum exercise intensity in type 2 diabetes mellitus -validity of double product break point method-
Scientific Title To investigate of optinum exercise intensity in type 2 diabetes mellitus -validity of double product break point method-
Scientific Title:Acronym To investigate of optinum exercise intensity in type 2 diabetes mellitus -validity of double product break point method-
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study on non-invasive estimation method of lactate threshold in type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others To investigate the validity of the non-invasive method of measuring lactate threshold in type 2 diabetes.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood lactate acid during cardiopulmonary exercise test
Key secondary outcomes Measure the following items during cardiopulmonary exercise test.
Peak VO2, Anaerobic threshold, Lactic threshold, Blood pressure, Heart rate, Double product, Double product break point.
As other,HbA1c before cardiopulmonary exercise test, Function of Autonomic nerves(CVRR), Body composition, Muscle strength(grip, leg extension), Psychological burden.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 <Cardiopulmonary exercise test>
Using a bicycle ergometer, perform incremental load test. The exercise test is performed only once for one case. Simultaneously, exhalation gas analysis during exercise was performed.
Blood sampling is performed from the earlobe every minute during cardiopulmonary exercise test for measuring of blood lactic acid. Lactate pro 2 (ARKRAY, Inc.)is used for lactate measurement.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male
Key inclusion criteria Those satisfying the following conditions during screening.
1. Patients being treated by diet therapy, exercise therapy, oral hypoglycemic drugs and insulin therapy.
2. Patients with occasional blood glucose levels at screening of 300 mg / dL or less
3. Informed consent has been obtained before participation in this research
Key exclusion criteria 1. Patients undergoing acute treatment for diabetes (patients with diabetes ketoacidosis, diabetic coma, etc.)
2. type 1 diabetic patients
3. Patients with a history of cerebral cardiovascular disease
4. Patients with a history of ischemic heart disease
5. Patients with respiratory illness during treatment
6. Patients with apparent renal dysfunction (serum creatinine> 1.4 mg/dL)
7. Patients with severe liver dysfunction
8. Patients taking oral administration of beta-blocker
9. Patients using steroid
10. The one judged by the doctor as inadequate from the result of the medical check for exercise therapy
11. Others considered to be inappropriate at the discretion of a doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuta
Middle name
Last name Kodama
Organization Kyorin University Hospital
Division name Department of Rehabilitation
Zip code 181-8611
Address 6-20-2 Shinkawa, Mitaka city, Tokyo
TEL 0422475511
Email kodamayuta29@gmail.com

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Kodama
Organization Kyorin University Hospital
Division name Department of Rehabilitation
Zip code 181-8611
Address 6-20-2 Shinkawa, Mitaka city, Tokyo
TEL 0422475511
Homepage URL
Email kodamayuta29@gmail.com

Sponsor
Institute Kyorin University Hospital
Institute
Department

Funding Source
Organization Kyorin University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Medicine Research Ethics Committee, Kyorin University
Address 6-20-2 Shinkawa, Mitaka-city, Tokyo
Tel 0422475511
Email rec@ks.kyorin-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 12 Day
Date of IRB
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2020 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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