UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044304 |
|---|---|
| Receipt number | R000050569 |
| Scientific Title | A prospective observational study to investigate the relationship between instability of glucose variability with age and diabetes-related complications or disorders in Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/06/14 17:21:13 |
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Basic information
Public title
A prospective observational study to investigate the relationship between instability of glucose variability with age and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Acronym
The relationship between instability of glucose variability with age and diabetes-related complications or disorders
Scientific Title
A prospective observational study to investigate the relationship between instability of glucose variability with age and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Scientific Title:Acronym
The relationship between instability of glucose variability with age and diabetes-related complications or disorders
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to investigate whether instability of glucose variability with age is associated with the onset and worsening of diabetes-related complications or disorders in Japanese patients with type 2 diabetes using continuous glucose monitoring.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between instability of glucose variability with age and endogenous insulin secretion in Japanese patients with type 2 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the change in glucose variability and clinical characteristics, glucose-related parameters or insulin secretion
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) The patients with type 2 diabetes enrolled in the previous research (UMIN000029993) who have been getting outpatient treatment for over 1 year
2) 20 years of age or more
3) Patients undergoing continuous glucose monitoring
4) Written informed consent
Key exclusion criteria
1) Patients hospitalized within the past three months
2) Severe diabetic ketosis, diabetic coma within the past six months
3) Pregnancy, nursing woman or possibly pregnant woman
4) Patients who are taking kinds of steroid
5) Type 1 diabetes
6) Severe infection, pre and post operation, severe trauma
7) Patients having difficulty in dietary intake
8) Patients who are undergoing intermittently scanned continuous glucose monitoring
9) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Nakamura |
Organization
Hokkaido University Hospital
Division name
Internal medicine II
Zip code
060-8638
Address
N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
akinbo@tim.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | Akinobu |
| Middle name | |
| Last name | Nakamura |
Organization
Hokkaido University Hospital
Division name
Internal medicine II
Zip code
060-8638
Address
N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
akinbo@tim.hi-ho.ne.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
North 14, West 5, Kita-ku, Sapporo , Hokkaido
Tel
011-706-7061
none@none
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
北海道大学病院（北海道）
NTT東日本札幌病院（北海道）
苫小牧市立病院（北海道）
釧路赤十字病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 01 | 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
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study.
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050569
