UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032143 |
|---|---|
| Receipt number | R000036617 |
| Scientific Title | The association between glucose variability and diabetes complications in patients with diabetes(Hyogo Diabetes Hypoglycemia Cognition Complications study) |
| Date of disclosure of the study information | 2018/04/07 |
| Last modified on | 2020/10/22 21:26:21 |
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Basic information
Public title
The association between glucose variability and diabetes complications in patients with diabetes(Hyogo Diabetes Hypoglycemia Cognition Complications study)
Acronym
The association between glucose variability and diabetes complications
Scientific Title
The association between glucose variability and diabetes complications in patients with diabetes(Hyogo Diabetes Hypoglycemia Cognition Complications study)
Scientific Title:Acronym
The association between glucose variability and diabetes complications
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus, Type 2 diabetes mellitus, Other diabetes mellitus, Prediabetes, Hypertension, Dyslipidemia, Obesity, Chronic kidney disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate relationships between glucose variability and diabetes complications in patients diabetes.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of dementia and mild cognitive impairment
Key secondary outcomes
Progression of diabetes complications and other complications
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Have at least one of diabetes mellitus(type 1 diabetes mellitus, type 2 diabetes mellitus, other diabetes mellitus, prediabetes), hypertension, dyslipidemia, obesity, chronic kidney disease
2.HbA1c under 10%
3.More than 8 weeks before the trial registration, those without change in the usage and dosage of the therapeutic agent
Key exclusion criteria
1.Patients of dementia
2.Other reasons leading the physician in charge to judge that the patient was unsuitable.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Koyama |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6592
ma-oohigashi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | Ohigashi |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6592
Homepage URL
ma-oohigashi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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 | 04 | Month | 07 | 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
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In progress
Management information
Registered date
| 2018 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036617
| 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 |
