UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000038276