UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039330 |
|---|---|
| Receipt number | R000044857 |
| Scientific Title | The study investigating the factors to determine glucose variabilities |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2023/03/27 13:06:21 |
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Basic information
Public title
The study investigating the factors to determine glucose variabilities
Acronym
GV-2 Study
Scientific Title
The study investigating the factors to determine glucose variabilities
Scientific Title:Acronym
GV-2 Study
Region
| Japan |
Condition
Condition
glucose intolerance
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the factor to determine glycemic variability
Basic objectives2
Others
Basic objectives -Others
glucose effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the index of glycemic variabilty
insulin secretion
insulin resistance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
to measure glycemic variabilities on daily life
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age more than 20 years
Fasting blood glucose level below 130 mg/dL
Key exclusion criteria
post gastrectomy
post pancreatomy
drug (affecting glucose tolerance) user
other disease (affecting glucose tolerance) patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | KAZUHIKO |
| Middle name | |
| Last name | SAKAGUCHI |
Organization
Kobe University
Division name
Department of diabetolgy and endocrine
Zip code
658-0027
Address
7-5-1, Kusunoki-Chyo, Cyuo-ku, Kobe
TEL
0784125107
kzhkskgc@gmail.com
Public contact
Name of contact person
| 1st name | KAZUHIKO |
| Middle name | |
| Last name | SAKAGUCHI |
Organization
Kobe university
Division name
Department of diabetolgy and endocrine
Zip code
658-0027
Address
7-5-1, Kusunoki-Chyo, Cyuo-ku, Kobe
TEL
0784125107
Homepage URL
kzhkskgc@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Donation
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
Ethics committee of Kobe university
Address
7-5-1, Kusunokicyo, Cyuo-ku, Kobe
Tel
0784125107
rinri@med.kobe-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
| 2020 | Year | 03 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044857
