UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024533 |
|---|---|
| Receipt number | 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 09:20:07 |
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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
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
takeshita@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa university hospital
Department of Disease Control and Homeostasis
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
