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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024533
Receipt No. R000028238
Scientific Title Intensity and timing of exercise for controling postprandial hyperglycemia in patients with type 2 diabetes
Date of disclosure of the study information 2016/10/24
Last modified on 2016/10/24

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Basic information
Public title Intensity and timing of exercise for controling postprandial hyperglycemia in patients with type 2 diabetes
Acronym Exercise protcol for postprandial hyperglycemia
Scientific Title Intensity and timing of exercise for controling postprandial hyperglycemia in patients with type 2 diabetes
Scientific Title:Acronym Exercise protcol for postprandial hyperglycemia
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The inhibitory effect of postprandial blood glucose level due to the difference in the exercise intensity for type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison the area under the concentration-time curve of blood glucose concentration for 4 hours between exercise intensity.
Key secondary outcomes 1. Correlation between the blood glucose value AUC for 4 hours after lunch and selenoprotein P concentration , general findings , and laboratory values.
2. Comparison between the blood glucose value AUC for 4 hours after lunch and exercise start time.
3. Relation between the blood glucose value AUC for 4 hours after lunch and gene expression.

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Day1: a 60-minute bicycle ergometer exercise at 25% HRMax from postprandial 1 hour
Day2: a 30-minute bicycle ergometer exercise at 50% HRMax from postprandial 1 hour
Day3: a 20-minute bicycle ergometer exercise at 75% HRMax from postprandial 1 hour
Day4: a 30-minute bicycle ergometer exercise at 50% HRMax from postprandial 2 hour
Day5: no exercise
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Type 2 Diabetes
2. Patients with exercise therapy has been formulated in diabetes education hospitalization.
Key exclusion criteria Poorly controlled hypertension
None type 2 diabetes
Insulin treatment
B2 blocker use patient
Positive anti-GAD antibodies
Kidny disease(stage 3 or later)
Pregnant or lactating women
Inability to participate in the study as assessed by the investigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinari Takamura
Organization Kanazawa University Graduate School of Medical Sciences
Division name Comprehensive Metabology, Kanazawa University Graduate School of Medical Sciences
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumie Takeshita
Organization Kanazawa university hospital
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Homepage URL
Email takeshita@m-kanazawa.jp

Sponsor
Institute Kanazawa university hospital
Department of Disease Control and Homeostasis
Institute
Department

Funding Source
Organization Kanazawa university hospital
Department of Disease Control and Homeostasis
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2070-1
Org. issuing International ID_1 Kanazawa university
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 金沢大学附属病院 恒常性制御学
小松ソフィア病院 内分泌代謝内科

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 24 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 Open public recruiting
Date of protocol fixation
2016 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2016 Year 10 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028238

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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