UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029698 |
|---|---|
| Receipt number | R000033943 |
| Scientific Title | Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study. |
| Date of disclosure of the study information | 2017/10/25 |
| Last modified on | 2019/10/28 23:06:36 |
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Basic information
Public title
Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Acronym
HD-induced hypoglycemia and glycemic disarrays in diabetic patients.
Scientific Title
Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Scientific Title:Acronym
HD-induced hypoglycemia and glycemic disarrays in diabetic patients.
Region
| Japan |
Condition
Condition
Diabetic hemodialysis patients
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively analyze the glycemic profiles on both hemodialysis day / non-hemodialysis day in diabetic hemodialysis patients by continuous glucose monitoring (CGM) and reveal of the hemodialysis-induced hypoglycemia and glycemic disarrays often, factors that contribute to them.
Basic objectives2
Others
Basic objectives -Others
Glycemic profiles by CGM, HbA1c and glycated albumin.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of hemodialysis-induced hypoglycemia and glycemic disarray and its factors.
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
Diabetic hemodialysis patients who previously attached CGM in Kitasato University Hospital and Soubudai Nieren Clinic
Key exclusion criteria
(1) Patients with insufficient CGM data
(2) Patients with insufficient blood test results
(3) Patients who refused to participant this study
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8706
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8706
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine, Department of Endocrinology, Diabetes and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Soubudai Nieren clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
042-778-8273
rinrib@med.kitasato-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
北里大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 25 | 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
138
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
During data analysis
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 17 | Day |
Date analysis concluded
Other
Other related information
Diabetic hemodialysis patients
Continuous glucose monitoring
Hemodialysis-related hypoglycemia
Hemodialysis-induced glycemic disarrays
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033943
| 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 |
